Guidelines for urological laparoscopic surgery
The Japanese Society of Endourology and ESWL
Urological Laparoscopic Surgery Guideline Committee
Masatoshi Tanaka md phd, Department of Urology, Fukuoka University Faculty of Medicine, 45-1 7-chome, Nanakuma, Jonan-ku, Fukuoka-shi 814-0180, Japan. Email: firstname.lastname@example.org~u.ac.jp
In recent years, minimally invasive laparoscopic surgical techniques have been developed in the various specialties, and applied to ever increasing patient numbers. Serious complications do occur sometimes, however, constituting a major social problem. This has created an urgent need for standardized indications for laparoscopic surgery, based on high-quality evidence, which will allow patients to undergo surgery with confidence. With this social background in mind, in April 2008 the Japanese Society of Endourology and ESWL published therapeutic guidelines for six representative laparoscopic procedures in the urological field, including laparoscopic adrenalectomy, laparoscopic radical nephrectomy, laparoscopic nephroureterectomy, laparoscopic radical prostatectomy, laparoscopic donor nephrectomy and laparoscopic pyeloplasty. These guidelines aim to provide information, conforming to the principles of evidence-based medicine, related to indications, diagnosis and surgical techniques, with the aim of improving clinical skill levels. These guidelines are intended to offer information about urological laparoscopic procedures to general medical practitioners and specialists, as well as patients and their families.
In this paper, we present an overview of the guidelines for six urological laparoscopic procedures.
Guideline formulation process
For the literature search in formulating these guidelines, we used PubMed for English language publications, and Japana Centra Revuo Medicina for Japanese language publications. Keyword-based searches were performed on 10 May 2005, with no restrictions on the date of publication. The final numbers of adopted references with structured abstracts were 82 for laparoscopic adrenalectomy, 41 for laparoscopic radical nephrectomy, 42 for laparoscopic nephroureterectomy, 132 for laparoscopic radical prostatectomy, 56 for laparoscopic donor nephrectomy, and 34 for laparoscopic pyeloplasty: a total of 387. The evidence level for these references was graded I to VI, and the number of references with structured abstracts at each evidence level quoted in these guidelines is shown in Table 1. Grades of recommendation are based on overall consideration of factors including the level of evidence in the reference material. However, the literature contains very little high-level evidence, such as large-scale randomized controlled trials, related to each laparoscopic procedure, so we have not given grades of recommendation, but rather stated the level of evidence for each reference source in the reference section. In this paper, we will only quote representative sources.
Table 1. Evidence levels for reference material
|II||At least one randomized controlled trial||1|
|III||Non-randomized controlled trials||18|
|IV||Analytic epidemiological studies (cohort or case–control studies)||72|
|V||Descriptive studies (case series, case reports)||273|
|VI||Opinions of authorities or expert committees, not based on patient data||12|
Laparoscopic adrenalectomy for adrenal tumors
Indications for laparoscopic adrenalectomy
The indications for laparoscopic adrenalectomy are functional benign tumors, such as primary aldosteronism, Cushing's syndrome, and pheochromocytoma, and non-functioning benign tumors, such as ganglioneuroma, non-functioning adenoma, myelolipoma, and cyst.1–3 In general, laparoscopic resection for pheochromocytoma is considered difficult, but there should be no problems with safety in the hands of an experienced surgeon with careful preoperative and intraoperative management, including blood pressure control. Laparoscopic surgery for malignant adrenal tumors was contraindicated, due to the high risk of peritoneal dissemination, port site recurrence, and local recurrence.4 Recent studies have shown, however, that relatively small solitary adrenal metastases (e.g. lung, renal and colorectal cancer) rarely invade beyond the adrenal capsule, and results with laparoscopic resection are comparable to those with open procedures in terms of positive surgical margin rates and survival rates.4,5 Debate continues over the application of laparoscopic adrenalectomy for primary adrenocortical cancer, and further study will be required before a consensus can be reached.4,5 An open procedure is indicated in cases of malignancies with local invasion, multiple systemic metastases, or a surgical history of the local site.4
The initial indication for laparoscopic adrenalectomy was a benign tumor less than 5–6 cm in diameter. The indications have more recently expanded to include tumors greater than 5–6 cm in size.6 A number of reports have suggested an upper limit of 10–12 cm due to the technical demands and the increased possibility of malignancy.6
There are four possible laparoscopic approaches to the adrenal glands, each with its advantages and disadvantages. Selection of the approach to be used depends on the experience of the surgeon, but in general less experienced surgeons should take a transperitoneal approach, providing greater space and allowing observation of the organs as familiar anatomical landmarks within the abdominal cavity.7 For adrenal tumors up to 5–6 cm in diameter, an anterior transperitoneal approach is recommended for right-sided lesions, and a lateral transperitoneal approach for left-sided lesions. When the size of the tumor exceeds 5–6 cm, the transperitoneal lateral approach is recommended for both left and right tumors. In addition, a transperitoneal approach, facilitating recognition of landmarks, is recommended for obese patients, and a retroperitoneal approach for patients with a history of abdominal surgery, in whom adhesions can be anticipated.7
There is considerable debate over surgical resection for incidentally discovered adrenal tumor (incidentaloma). The National Institute of Health (NIH) State-of-the-Science Statement regarding adrenal incidentalomas states that surgical resection is indicated for functional tumors and non-functioning tumors greater than 6 cm in diameter.8 Observation only is recommended for non-functioning tumors smaller than 4 cm. Surgical resection is strongly recommended for non-functioning tumors of 4–6 cm in size that show a rapid increase in size, with radiological findings that tend to exclude adenoma, such as a low lipid content. The choice of laparoscopic or open surgery depends on the possibility of invasive adrenocortical cancer, technical considerations, and the experience of the surgical team.
The collated results of reports of laparoscopic adrenalectomy for various adrenal tumors, with series of at least 50 patients each, showed that most studies reported a mean operative time of 1.5–3 h, mean blood loss of 30–100 mL, mean hospital stay of 2–6 days, and conversion to an open procedure in 0–5% of cases.3,9–11 A systematic review of reports of laparoscopic adrenalectomy with series of at least 40 patients each yielded a complication rate, including intraoperative and postoperative complications, of approximately 10% of the total 2550 cases.3 The most common intraoperative complication was hemorrhage, accounting for 18.5% of the total. The blood transfusion rate was low at 2.1%, however. Organ injuries accounted for 4.2% of intraoperative complications; the organs damaged included the liver, spleen, pancreas, kidney, bowel and diaphragm. Hemorrhage was also the most common postoperative complication, accounting for 21.5% of the total. This was followed by wound complications (hematoma, infection, etc.), urinary tract infection and thromboembolism. The reported mortality rate is 0.2%. According to the national survey conducted by the Japan Society for Endoscopy Surgery, 4909 laparoscopic adrenalectomies were performed in Japan between 1992 and 2005.1 Of these, 159 (3.2%) were converted to an open procedure. Intraoperative complications were reported in 232 cases (4.7%), including hemorrhage (cases requiring conversion to an open procedure to achieve hemostasis), visceral injuries and CO2 embolism. Postoperative complications were reported in 142 cases (2.9%), including wound infection, hemorrhage, respiratory complications and peritonitis. Postoperative laparotomy for complications was required in 21 cases (0.4%). There was one surgery-related death (0.02%).
Minimal invasiveness (comparison with open procedure)
We analyzed reports of laparoscopic procedures with series of at least 20 patients.10,12–14 Many studies have reported a significantly longer operative time for laparoscopic than open procedures, although the operative time can be reduced with the learning curve effect. Many studies have reported significantly less blood loss, and a lower rate of complications, for laparoscopic procedures. Significantly lower postoperative analgesia requirements, and significantly faster recovery, are also reported for laparoscopic than open procedures. There are, at present, few high-level evidence studies of the invasiveness of laparoscopic surgery, but laparoscopic procedures are less invasive than open procedures.
Laparoscopic partial adrenalectomy
Laparoscopic partial adrenalectomy is performed with the aim of preserving adrenal function.15 However, as a result of investigating all resected tissue specimens of the adrenal gland, multiple nodules were seen in approximately 10% of cases,16 and in particular in cases of primary aldosteronism, multiple nodules were present in 20% or 25% of specimens.16,17 A case of persistent hypertension and elevated plasma aldosterone levels following partial adrenalectomy, thought to be due to undetected micronodules in the ipsilateral adrenal gland, has been reported.17 The indication for laparoscopic partial adrenalectomy should therefore be considered carefully in light of the risk of incomplete resection and recurrence.
Although there is, at present, a lack of high-level supportive evidence, laparoscopic adrenalectomy is less invasive than open surgery. Many studies report a significantly longer operative time for laparoscopic adrenalectomy than for the open procedure, but these can be reduced with the learning curve effect. From the above, laparoscopic adrenalectomy is a standard technique, and should become the treatment of first choice, for benign adrenal tumors less than 5–6 cm in size. Further studies are needed to determine the indications for laparoscopic adrenalectomy for malignant lesions, in particular primary adrenocortical cancers.
Laparoscopic radical nephrectomy for renal cell carcinoma
Laparoscopic radical nephrectomy for renal cell carcinoma is a procedure in which the renal vessels are dissected without disturbing the tumor, and the kidney is dissected as a single mass with the adrenal gland and perirenal fat enclosed in the renal fascia, under laparoscopic control.18,19
Laparoscopic radical nephrectomy can be performed using a transperitoneal or retroperitoneal approach; the procedure can be conventional18–31 or hand-assisted laparoscopic surgery (HALS).32–34
The resected kidney is extracted from the abdominal cavity by placing it in a retrieval bag and either removed intact or made smaller by fractionation, and withdrawn through the appropriately sized incision. The position of laparoscopic incisions can be changed, reducing postoperative pain and exercise impairment.19,22,23,27
Indications for laparoscopic radical nephrectomy
A number of studies recommend laparoscopic radical nephrectomy for stage I localized renal cell carcinoma, as there are no differences between open and laparoscopic procedures in terms of antitumor effect as measured by disease-free survival rates or overall survival rates. Furthermore, laparoscopic procedures are associated with fewer intraoperative and postoperative complications, a lower analgesic requirement, and shorter postoperative hospital stays.20–23,25,29,31 However, laparoscopic procedures can sometimes be extremely difficult technically due to the tumor size or position.
Some institutions have reported surgical results comparable to those achieved with open surgery for laparoscopic resection of Stage II renal tumors and metastatic renal tumors. There have also been reports of successful laparoscopic treatment of tumor emboli of the renal veins, and T4 renal tumors, so further studies are required with increased patient numbers to determine long-term outcomes.24,26,28
Laparoscopic surgery for renal cell carcinoma is no longer confined to Stage I and II localized disease, but has recently become one of the standard treatments for renal cell carcinoma, performed in Stage III cases with renal vein tumor emboli, and as cytoreductive surgery for resection of the primary tumor in Stage IV disease with distant metastases.24,26,28 For localized renal cell carcinoma, operative times of 3–6 h and 100–300 mL blood loss have been reported, indicating longer operative times than open procedures but less blood loss.20–23,32,33 Conversion to an open procedure, due to hemorrhage or visceral injury, is reported in 3–8% of laparoscopic procedures.21,22,33 The incidence of complications associated with laparoscopic nephrectomy varies according to the inclusion criteria for complications adopted by each investigator, and is generally reported as similar to, or slightly higher than, open surgery.20–22,29,33 According to a national survey, 4878 laparoscopic radical nephrectomies were performed in Japan between 1992 and 2005, 3935 pure laparoscopic procedures and 913 HALS. There were three deaths (0.06%).1
A major difference between laparoscopic and open surgery is that the incisions are extremely small in the former. Minimal invasiveness is the greatest advantage of laparoscopic radical nephrectomy, accounting for the explosive growth in patient numbers undergoing this procedure worldwide. The mean hospital stay for laparoscopic procedures is 4.8 days, considerably shorter than that of 8.4 days for open procedures, and the return to normal activity 3.2 weeks after a laparoscopic procedure is also significantly shorter than that of 7.4 weeks after an open procedure. Analgesia requirements following laparoscopic surgery are between 1/7 and 1/2 of those following open surgery.19–25,32
If the proper procedures are followed (e.g. placing the resected kidney in a retrieval bag), port site recurrence, a characteristic complication of laparoscopic surgery where dissemination or metastasis of cancer is seen at the instrument ports, is rarely seen. The incidence of local recurrence is similar to that seen with open surgery.26,27,29,30,34
A study comparing the long-term anticancer effect in patients with cT1 or 2N0M0 renal cell carcinoma, in 64 patients who underwent laparoscopic radical nephrectomy and 69 patients who underwent open radical nephrectomy, found that that the 5-year disease-free survival rate was 92% for the former and 91% for the latter. The 5-year overall survival rates were 81% and 89%, respectively, so the authors concluded that there was no difference between the anticancer effect of the two procedures.29 A subsequent comparative study also reported a 5-year disease-free survival rate of 91% and a 5-year cancer-specific survival rate of 94% for patients following laparoscopic radical nephrectomy for Stage I renal cell carcinoma, and no significant difference to the respective rates of 87% and 94% following open radical nephrectomy. Similarly, no difference in anticancer effect has been seen between laparoscopic and open radical nephrectomy in the anticancer effect for patients with Stage II renal cell carcinoma.21,23,28,31 Patient numbers are small for laparoscopic radical nephrectomy for Stage III and IV advanced disease, and further studies are needed. Follow up for 2–3 years has revealed no difference in overall survival rates between laparoscopic cytoreductive surgery for primary renal cell carcinoma in patients with metastatic disease and open procedures.24,26,28
Although there are, at present, no high-level supportive studies, laparoscopic radical nephrectomy is considered less invasive than open surgery, and although operative times are longer, blood loss is reduced. A number of reports have found the anticancer effect to be similar for laparoscopic and open procedures in patients with localized renal cell carcinoma, and laparoscopic radical nephrectomy is considered the standard treatment for Stage I disease. The choice of technique in patients with Stage II disease depends on whether laparoscopic resection is technically feasible. Further studies are needed to address the question of the indications for laparoscopic surgery for advanced Stage III and IV renal cell carcinoma, due to the high degree of technical difficulty and the dearth of reports of long-term results.
In addition, we will address the question of surgical resection of lymph nodes and adrenal glands in the treatment of renal cell carcinoma. Studies finding no merit in lymph node dissection have led to radical nephrectomy being widely performed without lymph node dissection, even in open procedures, and this has increasingly become the standard treatment. Adrenal-sparing radical nephrectomy and partial nephrectomy for smaller cancers, are also being performed, and the definition of radical nephrectomy itself is changing. These guidelines have concentrated on the technical aspects of laparoscopic radical nephrectomy for renal cell carcinoma, and we plan to leave the discussion of whether lymph nodes or adrenal glands should be resected at the time of radical nephrectomy to another time, and abide by the conclusions reached at that time.
Laparoscopic nephroureterectomy for upper tract urothelial carcinoma
Indications for laparoscopic nephroureterectomy
From the results of a number of retrospective descriptive studies, laparoscopic nephroureterectomy is indicated in patients with upper tract urothelial carcinoma up to clinical stage T2, with no evidence of lymph node metastases. No conclusions can be made about patients with stage T3 disease due to the lack of comparative trials stratified for clinical stage. Laparoscopic surgery is not contraindicated in patients with stage T3–4 disease, as a similar anticancer effect to open surgery has been demonstrated in studies including this patient group.
Laparoscopic-assisted nephroureterectomy is indicated in patients with advanced ureteric carcinoma, where nephrectomy is performed laparoscopically, and resection of ureteric tumor as an open procedure.
There have been few reports of laparoscopic nephroureterectomy in patients with tumor invasion of adjacent organs, or widespread lymph node metastases, and further studies are needed in this area. Only a limited number of studies have addressed the question of the indications, appropriate range and techniques for lymph node dissection in association with laparoscopic nephroureterectomy.
The collated results of reports of laparoscopic nephroureterectomy for upper tract urothelial tumors, with series of at least 20 patients each, showed that most studies reported a mean operative duration of 4–6 h for laparoscopic, laparoscopic-assisted and hand-assisted procedures alike. The average blood loss was 200–500 mL, the mean hospital stay 4–10 days, and conversion to an open procedure occurred in 0–10% of cases.35–45 In another study, five out of 116 patients (4%) at five institutions were converted to an open procedure.46 A review of reports of laparoscopic nephroureterectomy, collating results for 377 patients, yielded a mean operative duration of 276.6 min, a blood loss of 240.9 mL, a minor complication rate of 12.9%, and a major complication rate of 5.6%.36 According to a national survey, 2435 laparoscopic nephroureterectomies were performed in Japan between 1992 and 2005, 1960 laparoscopic procedures and 913 HALS. There were two surgery-related deaths (0.08%).1
We were unable to identify any randomized controlled trials that compared laparoscopic and open procedures. Most reports were of descriptive studies with case series, so we examined reports of laparoscopic nephroureterectomy series with at least 10 patients.35–41,47–50 We found one case–control study.
Operative time and blood loss
A review article that collated results for 377 patients found that although operative times are longer, blood loss is reduced for laparoscopic nephroureterectomy. A case–control study of 11 HALS patients and 11 patients who underwent open surgery matched for age, gender and American Society of Anesthesiologists (ASA) classification found no difference in operative times, and significantly less blood loss in the HALS group.49
Many descriptive studies have also found no difference in operative times between laparoscopic nephroureterectomy (including HALS) and open surgery,37,38,48 although some have reported laparoscopic surgery takes longer,39,40,50 and some have even found laparoscopic surgery to be shorter.35 The majority of studies have found intraoperative blood loss to be less with laparoscopic than open surgery.35,38–40,47,48 From the above, we conclude that operative times are the same or slightly longer, and blood loss is less with the laparoscopic procedure compared to open surgery.
A review of 15 laparoscopic nephroureterectomy series (total 312 patients) and 11 open nephroureterectomy series (total 206 patients) revealed a major complication rate of 0–19% (mean 5.6%) for laparoscopic surgery, and 0–29% (mean 8.3%) for open surgery. The minor complication rate was 0–40% (mean 12.9%) for laparoscopic surgery, and 0–45% (mean 14.1%) for open surgery. No difference was seen between procedures.36 Other descriptive studies also reported no difference in the rate of complications between laparoscopic and open surgery.35,37–39 Complications specific to laparoscopic nephroureterectomy were leakage of large volumes of irrigation fluid during transvesical dissection of the distal ureter,35 urinary leakage from the stapled vesical closure site,39 and port-site hernia.45
Postoperative pain and recovery time
The above-mentioned case–control study of 11 HALS patients and 11 open surgery patients found that the duration of extradural anesthesia and hospital stays were significantly shorter in the former group.49 Other studies found that laparoscopic surgery was superior to open surgery in terms of the time until patients walked postoperatively,35,38 the time until resuming eating,35,38,40,47,48,50 postoperative analgesia requirement,35,38–40,48 hospital stay,35,38,40,47,48,50 and postoperative recovery time.35,38–40,47,50 No studies reported superiority for open surgery. Although our search revealed no prospective randomized controlled trials, postoperative recovery tends to be faster following laparoscopic than open nephroureterectomy. A study examining the effects of surgery on body shape using computed tomography scanning, found that there was less distortion of body shape following laparoscopic nephroureterectomy, which does not leave a large upper abdominal wound, than an open procedure.51
Studies of postoperative anticancer effect of laparoscopic nephroureterectomy, with series of at least 20 patients, reported vesical recurrence in 4.5–55.5% of cases,35,36,39–46,52 distant metastases in 0–28%,35,36,39–46 local recurrence in 0–15%,36,39–41,43,45,46 2-year cancer-specific survival rates of 77–94%,39,46 a 5-year cancer-specific survival rate of 81%,36 and a 5-year metastasis-free survival rate of 72%.41
Comparison with open surgery
A review of studies published between 1991 and 2004 that compared laparoscopic nephroureterectomy (including HALS) and open surgery found that the average postoperative vesical recurrence rate was 24.0% for the former and 24.7% for the latter, local recurrence rates were 4.4% and 6.3%, respectively, and the rates of distant metastasis were 15.5% and 15.2%. The average 2-year cancer-specific survival rates were 75.2% and 76.2%, and the 5 year overall survival rates were 81.2% and 61%, respectively.36 A study that compared outcomes following laparoscopic and open surgery over a 7-year follow-up period found no differences in rates of local recurrence, vesical recurrence, or 1- and 5-year metastasis-free survival rates.41 Other descriptive studies have also reported no differences in positive surgical margin rates,35 postoperative vesical recurrence rates,40 or local recurrence rates.40 The proportion of patients with Stage pT3 tumors in these studies was 12–35% in the laparoscopic group, and 18–59% in the open group, with no difference between groups in most studies. There have been no studies that report significantly higher recurrence rates, or lower survival rates, with laparoscopic nephroureterectomy than with open surgery. The lack of studies with follow-up periods greater than 5 years makes it impossible to draw any definitive conclusions, however.
Port-site recurrence is a problem with laparoscopic procedures that use pneumoperitoneum and small incisions. There have been seven reported occurrences, some thought to be caused by withdrawal of a specimen through a small incision without using a retrieval bag, and some cases of port-site metastasis unrelated to tissue retrieval.36,42 Port-site recurrence is more common in patients with highly malignant Grade 3 disease. When performing laparoscopic surgery for upper tract urothelial cancer, to prevent pneumoperitoneum-associated tumor dissemination and port-site recurrence, it is essential that the tumor and ureter should not be damaged, and that the resected specimen is placed in a retrieval bag before removal from the body if a sufficiently spacious incision is not available.
Although there are, at present, no high-evidence-level prospective controlled trials, laparoscopic nephroureterectomy is considered less invasive than open surgery. Some studies have reported that operative times are longer than with open procedures, although with improved techniques laparoscopic procedures can become similar in duration or even shorter. A number of studies have found the anticancer effect to be similar for laparoscopic and open nephroureterectomy, but the short follow-up periods make it impossible to draw any definitive conclusions. Port-site recurrence has been reported with high-grade tumors, requiring added caution. From the above, laparoscopic nephroureterectomy is a minimally invasive procedure suitable for early upper tract urothelial cancer. The question of the indications for laparoscopic surgery for advanced cancer requires further study.
The technique for management of the distal ureter should be selected according to the tumor site and staging, so as to avoid cancer cell dissemination, and resection should include the ureteral orifice. Laparoscopic lymph node dissection should be performed in the same fashion as an open procedure.
Laparoscopic radical prostatectomy for prostate cancer
Indication for laparoscopic radical prostatectomy
Indication for laparoscopic radical prostatectomy is localized prostate cancer. Favorable therapeutic results are obtained with a prostate-specific antigen (PSA) level <10 ng/mL, Gleason score ≤7, and T1c–T2b disease, so these are considered the ideal criteria. On the other hand, PSA ≥8 ng/mL, Gleason score ≥8 or localized T3 disease are not necessarily contraindications for laparoscopic radical prostatectomy,53 but consideration should be given to life expectancy and quality of life (QOL) in choosing treatment options.
The collated results of reports of laparoscopic radical prostatectomy, with single center series of at least 200 patients each, showed a mean operative time of 2.5–4.0 h, average blood loss of 220–380 mL, average catheterization time of 4.8–7.6 days, blood transfusion rate of 0.9–6.0%, and conversion to open procedure in 0–2% of cases.54–58
A systematic review of laparoscopic radical prostatectomy found an intraoperative complication rate of 17.1%, with complications necessitating further surgery occurring in 3.7% of cases.59 Reported complications included hemorrhage and damage to the bowel, urinary tract (bladder, urethra or ureter), blood vessels or nerves (obturator nerve).60,61 Rectal damage, a serious complication, occurred in 1–2% of laparoscopic procedures: as with open procedures, if discovered during the operation, immediate repair makes primary healing possible.60,61 Complications are more common with inexperienced operators, so as operators upgrade their skills the frequency of complications can be reduced.59 A Japanese survey collated the results for 276 laparoscopic radical prostatectomies, finding that 28 (10.1%) were converted to an open procedure.62 The main intraoperative complications were subcutaneous emphysema in 28 cases (10.1%), vesical damage in 15 (5.4%), rectal damage in 11 (4.0%), and ureteric damage in three (1.1%). Further surgery was required in three cases (1.1%), and blood transfusion in 37 (13.4%).
Minimal invasiveness: Comparison with open procedure
We were unable to identify any randomized controlled trials that compared laparoscopic radical prostatectomy and open surgery, namely radical retropubic prostatectomy. Most reports were non-randomized controlled trials,63–65 and our search also found two systematic reviews.66,67
Operative time, blood loss and intraoperative complications
Examination of the non-randomized controlled trial results reveals that operative times are longer, but blood loss is reduced and transfusion required less often with laparoscopic radical prostatectomy in comparison to retropubic radical prostatectomy. The incidence of intraoperative complications was 4–17% for laparoscopic procedures, and 8.4–18% for open procedures, with no difference found between groups.68
Postoperative recovery, hospital stay and catheterization time
A study that compared postoperative pain levels using a pain scale found that on the first postoperative day, pain was significantly less in the laparoscopic surgery group (score 4) than in the open surgery group (score 7).69 Most studies found hospital stays were shorter following laparoscopic surgery.63 In the early experience of laparoscopic radical prostatectomy urinary leakage from the urethrovesical anastomosis was common, and catheterization times were similar to those after an open procedure.63 Catheterization times can be reduced as operators become more proficient in laparoscopic surgery, and the prospective study of reducing post-laparoscopic catheterization times conducted by Abbou et al. reported that catheters could be removed at 2–4 days post-procedure in 96 out of 113 patients (84.9%).70
Urinary continence and erectile function
A systematic review of the published reports up until 2003 found that the proportion of patients achieving urinary continence at 12 months postoperatively were 60–94% for laparoscopic surgery, and 61–98% for retropubic open surgery, with no difference seen between groups. The proportion of patients achieving potency was 34–67% for laparoscopic surgery, and 31–79% for retropubic open surgery, with no difference seen between groups.59 The Japanese survey of postoperative QOL by Hara et al. found that patients who underwent laparoscopic surgery expressed a favorable attitude to their surgery, but no difference was seen at 6 months postoperatively in urinary continence and sex life QOL between laparoscopic and retropubic open surgery.71 Contrastingly, the multicenter institutional collaborative study by Namiki et al. found that QOL related to micturition was poor at 1 month post-laparoscopic radical prostatectomy.65 The non-randomized prospective controlled trial by Roumeguere et al. also found that urinary continence was achieved earlier following retropubic open surgery than laparoscopic surgery.64 It is worth noting, however, that both these studies compared laparoscopic surgery, with a small series in terms of patient numbers, with open surgery, with greater accumulated patient numbers. In one study, the rate of recovery of erectile function following laparoscopic radical prostatectomy was 53.8% with unilateral preservation of neurovascular bundles, and 58.8% with bilateral preservation.72 The observation period was short, however, and further studies with longer follow-up periods are needed.
The anticancer effect of laparoscopic radical prostatectomy has been examined from the viewpoints of whether the surgical margins of the resected specimen are positive or not, and biochemical evidence of recurrence using PSA levels. Drawing only from reports collating results of at least 100 laparoscopic procedures, the overall positive surgical margin rate was 16–26%.59 Stratified by pathological stage, the positive surgical margin rate was 7.4–18.9% for pT2, and 25.2–42.0% for pT3s disease.73,74 Stratified by location, the respective rates were 44.4% for the apical region, 13.9% for the bladder neck region, and 41.6% for the posterolateral region.75 Stratified by Gleason scores, the rates were 0%, 15%, 21% and 30% for scores of 2–4, 5–6, 7, and 8–10, respectively.76 Analysis revealed preoperative PSA levels, clinical stage, pathological stage and Gleason scores to be predictive factors for positive surgical margins, but no correlation with preservation of the neurovascular bundles.76
Biochemical recurrence, as measured by PSA levels, was reported in 9.5–11.0% of all patients. Stratified by pathological stage, PSA recurrence was seen in 3.2–8.2% of patients with pT2a, 6.5–12.0% of patients with pT2b, 15.9–23.0% of patients with pT3a, and 23.9–56.0% of patients with pT3b disease.73,76
Abbou et al. compared the results of radical retropubic, radical perineal, and laparoscopic radical prostatectomy, reporting positive surgical margin rates of 18.9% for retropubic, 13.9% for perineal, and 18.9% for laparoscopic procedures. Stratified by location, the respective rates for the apical, bladder neck, and posterolateral regions were 50.0%, 29.1% and 20.8% for retropubic procedures, 33.3%, 41.7% and 25.0% for perineal procedures, and 44.4%, 13.9%, and 41.6% for laparoscopic procedures. The risk of positive surgical margins was relatively high for the apical region with retropubic, the bladder neck for perineal, and the apical and posterolateral regions for laparoscopic procedures.75
Although there are, at present, no high-evidence-level prospective controlled trials, laparoscopic radical prostatectomy is considered less invasive than open surgery. Some studies have reported that operative times are longer than with open procedures. Most studies have found no differences between laparoscopic and open procedures in anticancer effects or recovery of urinary continence and erectile function, although some reported that recovery of urinary continence was achieved earlier following open surgery compared to laparoscopic surgery. The degree of difficulty for laparoscopic radical prostatectomy is relatively high. In order to attain technical proficiency in this procedure, operators should depend not only on academic knowledge, but exercise common sense in avoiding extremely large prostates, as well as obese patients and those with a history of pelvic surgery. Furthermore, a thorough knowledge of the microanatomy in the prostatic region as seen through laparoscopic magnification, and proficiency in laparoscopic dissecting and suturing techniques, are needed for the safe, accurate and fast performance of laparoscopic radical prostatectomy.
Laparoscopic donor nephrectomy for living kidney transplantation
Indications for laparoscopic living donor nephrectomy
We were only able to find one prospective randomized controlled trial of hand-assisted laparoscopic and open nephrectomy,77 so we are unable to make any definitive statements about the indications for laparoscopic living donor nephrectomy, or the grades of recommendation. Consideration of the safety of the donor and preservation of the graft function suggests that, in the hands of a technically proficient operator with experience of at least 20 laparoscopic living donor nephrectomies, the indications for laparoscopic procedures are the same as for traditional open living donor nephrectomies.
Two studies compared laparoscopic and open living donor nephrectomy in cases of aberrant renal vasculature.78,79 Neither study found any differences in the rates of rejection or complications, early or late postoperative function of the transplanted kidney, or graft survival rates. When laparoscopic living donor nephrectomy was first commenced, however, kidneys with vascular duplication, obese donors, and right kidney transplantation were all relative contraindications, and careful donor selection in accordance with the proficiency of the operator is still necessary.
The collated results of reports of laparoscopic living donor nephrectomy (including HALS and extraperitoneal laparoscopic procedures) with series of at least 50 patients each, revealed the following: 95–98% left nephrectomies, mean operative duration of 202–253 min, average blood loss 128–334 mL, mean warm ischemia time 2.8–4.9 min, and average hospital stay of 2.5–3.3 days. The major complication rate was 0–7.6%, the minor complication rate 8.9–17.1%, conversion to an open procedure occurred in 0–2.1% of cases, and 0–3.4% required blood transfusions.80–82
Operative time and blood loss
Only the above-mentioned prospective randomized controlled trial compared HALS and open living donor nephrectomy. Some studies have reported that operative times are significantly longer for laparoscopic procedures than for open procedures,77,83,84 although others have found no difference.85–88 A more recent study even found that laparoscopic procedures have become shorter than open surgery.89 Blood loss has been reported to be significantly less,83 or the same88 for laparoscopic surgery in comparison to open surgery.
Postoperative pain and recovery time
Postoperative analgesic use is significantly less with laparoscopic surgery than with open surgery. Laparoscopic surgery was superior to open surgery in terms of the time until patients walked postoperatively, the time until resuming eating, postoperative hospital stay, and time until return to normal activities.77,83,85–88
Many studies found no significant difference between laparoscopic and open living donor nephrectomy in the incidences of intraoperative or postoperative complications.83,85,86,89
Reported gastrointestinal complications include retroperitoneal herniation of small bowel, port-site hernia, and following HALS, Spigelian hernia (lateral ventral hernia) and small bowel intussusception. Other complications include vesical damage, rhabdomyolysis, massive hemorrhage from the renal pedicle, and genitofemoral nerve damage.
Safety of the procedure, function of the transplanted kidney
The United Network for Organ Sharing (UNOS) conducted a survey of complications associated with open living donor nephrectomy (5660 cases) and laparoscopic living donor nephrectomy (5168), a total of 10 828 procedures. They reported one death due to pulmonary embolism following HALS, one death of unknown cause, and one patient left in a vegetative state following intraoperative hemorrhage and hypotension. Also, second-look surgery was required in 44 cases with the laparoscopic procedure. No deaths were reported associated with the 5660 open procedures performed in the same time period.90
Most studies have reported no difference in function of the transplanted kidney in the recipient between laparoscopic and open surgery.85–87,89 The UNOS survey also found no difference in transplanted kidney function, or the proportion of patients requiring dialysis, between groups.91
Management of renal vessels
In 2006, the American Society of Transplantation (AST) published the results of a survey of their members regarding laparoscopic donor nephrectomy. They received responses from 213 institutions, reporting 66 cases of renal arterial hemorrhage, resulting in two deaths and two cases of renal failure. Blood transfusion was required in 19 cases, and second-look operation or conversion to an open procedure in 29. Standard metal clips were used in all four cases resulting in death or renal failure. Intraoperative or postoperative delayed hemorrhage also occurred in eight cases in which non-absorbable locking clips (Hem-o-lock) were used. The AST concluded that, as the stump of the renal artery tends to be shorter with laparoscopic living donor nephrectomy, vascular transfixion is the safest method for achieving vascular control of the renal artery.92 At present, the recommended methods of managing the renal artery are oversewing or suture ligature, or mechanical methods using a GIA surgical stapler or TA surgical stapler.
Although there is, at present, no high-level evidence, laparoscopic living donor nephrectomy is considered less invasive than open surgery. Many studies have reported that operative times are longer compared with open procedures, although this difference can be reduced with improved operator proficiency. Most studies reported no difference in function of the transplanted kidney in the recipient between laparoscopic and open surgery, however, the follow-up period was not long enough for comparing the graft function in each procedure. Although most reports stated the complication rate was not significantly different in open and laparoscopic donor nephrectomy, the UNOS report, with large patient numbers, found a significantly lower complication rate in the open surgery group. Thorough attention should be given to the possibility of complications when performing laparoscopic living donor nephrectomy.
From the above, laparoscopic living donor nephrectomy is a minimally invasive surgical modality that should be performed by a surgeon experienced in laparoscopic surgery and transplant medicine. The American UNOS survey identified two deaths and one patient left in a vegetative state out of 5168 patients undergoing laparoscopic living donor nephrectomy. In Japan, this procedure should be performed by surgeons experienced in laparoscopic renal surgery and well versed in open living donor nephrectomy. Alternatively, surgeons experienced in the above-mentioned different surgical modalities could form a nephrectomy team. Institutions commencing laparoscopic living donor nephrectomy should do so under the direction of an accredited laparoscopist. Before performing this procedure, the surgeon should explain to the donor and their family the advantages and disadvantages of laparoscopic living donor nephrectomy, possible complications, the deaths reported from the USA, and the possibility of conversion to an open procedure, and obtain informed consent.
Laparoscopic pyeloplasty for ureteropelvic junction obstruction
Pyeloplasty is a surgical procedure that is indicated for improvement of hydronephrosis, and its associated symptoms, caused by ureteropelvic junction (UPJ) obstruction or a congenital abnormality of ureteric insertion. Most of the studies identified in our literature search deal with Anderson–Hynes (dismembered) pyeloplasty93 and Fenger (nondismembered) pyeloplasty94 together, so in these Guidelines we will not distinguish between the two, and refer to ‘laparoscopic pyeloplasty’, also including the retroperitoneal approach.
Hydronephrosis caused by UPJ obstruction is classified into congenital UPJ obstruction (stenosis),93 presenting as hydronephrosis in the fetal, infancy or older age, and adult onset stenosis, presenting as recurrent episodes of colic associated with intermittent bouts of hydronephrosis. The former is rarely associated with crossing vessels,95 but is usually caused by a congenital abnormality of the UPJ smooth musculature. Except for abnormal ureteric attachment, some cases of postnatal hydronephrosis gradually improve with time. Crossing vessels are sometimes seen in these cases, however, and will often cause rapidly progressive hydronephrosis and renal colic.96,97 It is therefore important to determine preoperatively whether crossing vessels are present in cases of suspected UPJ stenosis, as the result will greatly influence the operative technique chosen.97,98
Pyeloplasty techniques can be classified into: (i) techniques that preserve the connection between the renal pelvis and ureter while improving the drainage of urine down the ureter; and (ii) techniques that remove the narrowed portion of the UPJ (breaking the anatomical connection between the renal pelvis and ureter) and re-anastomose the UPJ. Anderson–Hynes pyeloplasty, in which the stenotic portion is removed and the renal pelvis re-anastomosed, is considered the standard open pyeloplasty technique.93 Although the clinical results of open pyeloplasty are extremely favorable, it does have the disadvantage of being highly invasive, with a large upper abdominal incision. Endopyelotomy, using a ureteroscope or nephroscope, was introduced to overcome this disadvantage, but has failed to achieve consistent results due to its inability to cope with extrinsic problems, such as crossing vessels. Laparoscopic pyeloplasty94 (using either the transperitoneal or retroperitoneal approach) is being introduced in a number of institutions to overcome the disadvantages of both of the above methods. In formulating these Guidelines for laparoscopic pyeloplasty, we placed the greatest weight on the evidence for laparoscopic Anderson–Hynes pyeloplasty99 and laparoscopic Fenger pyeloplasty,94 the two techniques that have been most extensively studied. Ureteral stent placement can be performed either preoperatively and retrogradely, or antegradely through the incision during the procedure.100
The indications for laparoscopic pyeloplasty are the same as those for traditional open pyeloplasty.
Laparoscopic pyeloplasty was initially confined to adults, but the miniaturization of laparoscopic equipment has allowed the indications to be extended to include infants, with similar surgical results to open surgery.101
Selection criteria for pyeloplasty type
Laparoscopic Fenger pyeloplasty94 is indicated in the following: patients with a small extrarenal pelvis, patients with no crossing vessels, and patients with a stenotic area <1 cm in length. In patients not meeting these criteria, laparoscopic Anderson–Hynes pyeloplasty99 is the treatment of first choice. Laparoscopic Anderson–Hynes pyeloplasty can also be considered in patients associated96 with renal lithiasis in the absence of urinary tract infection.
Surgical results: Comparison of laparoscopic and open pyeloplasty
Our search of the published reports yielded no reports of randomized controlled trials comparing open pyeloplasty,97 with laparoscopic pyeloplasty. We identified six case series comparing open and laparoscopic pyeloplasty. Although the mean follow-up times were short, ranging from 11 to 22 months, the success rates for laparoscopic pyeloplasty were 88–100%, with no significant difference to those of 86–100% for standard open pyeloplasty.102–107 Laparoscopic pyeloplasty is also effective in preserving blood flow in crossing vessels. Abdominal pain that was present preoperatively disappeared in 62–88% of patients following laparoscopic pyeloplasty, and in 60–68% following open pyeloplasty, representing a similar result. Immediate postoperative pain was significantly less with laparoscopic pyeloplasty,106,108 and hospital stays were markedly shorter following laparoscopic surgery at 1.4–5.8 days versus 2.3–13.4 days for open surgery.
In summary, we can say that in comparison with open surgery, procedure times are longer with laparoscopic pyeloplasty, success rates are similar, and the time taken to recover and return to previous activities is significantly shorter.
Minimal invasiveness: Comparison of open, endoscopic and laparoscopic pyeloplasty
The least invasive surgical treatment for UPJ stenosis is Acucise endopyelotomy.103 Reported hospital stays were 7.3 days for open pyeloplasty, 3.1 days for laparoscopic pyeloplasty, 3 days for percutaneous pyeloplasty, and 0.2 days for Acucise retrograde endopyelotomy.103 No reliable clinical studies have been published comparing the invasiveness of laparoscopic pyeloplasty and percutaneous pyeloplasty.
As laparoscopic pyeloplasty is a recent development in comparison with other procedures, there are only two published reports with follow-up periods longer than 12 months.94,109 With mean follow-up periods of 17 and 25 months, these studies report success rates of 97%109 and 98%,94 representing reasonably long-term results comparable to those achieved with open surgery.
Laparoscopic pyeloplasty shows similar efficacy and safety to the standard treatment, with reduced postoperative pain, and allows an earlier return to normal daily activities. It can be recommended as the treatment of first choice for all patients in whom open pyeloplasty, the present standard treatment, is indicated. In particular, if an experienced surgical team is available, laparoscopic pyeloplasty should be considered for the following cases, where the efficacy of endopyelotomy is questioned: (i) patients with crossing vessels; (ii) patients with a stenotic area <1 cm in length; and (iii) patients with hydronephrosis and a large extrarenal pelvis.