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Objective To evaluate the feasibility and safety of laparoscopic management of adnexal masses ≥10 cm in size.
Design Prospective cohort study.
Setting Two Gynecology Departments of University Hospitals.
Population All women presenting with an adnexal mass ≥10 cm in diameter were candidates for laparoscopic management. Women were excluded from laparoscopic approach if there was evidence of ascites or gross metastatic disease. Neither the sonographic features of the cyst nor elevated serum CA125 level was used to exclude women from having a laparoscopic approach.
Methods A single operative protocol was followed for all women. All removed specimens were sent for immediate pathological evaluation.
Main outcome measures Rate of conversion to laparotomy, incidence of cancer encountered, and operative complications.
Results One hundred and eighty-six women underwent laparoscopic evaluation for an adnexal mass of 10 cm or larger in size. The average preoperative mass size was 12.1 ± 4.9 cm. A benign pathological condition was found in 86.6% (161/186) of the women, primary ovarian cancer in 16 (8.6%) women, a metastatic tumour of gastrointestinal origin in 1 (0.5%) woman, and a low malignant potential ovarian tumour in 8 (4.3%) women. Laparoscopic management was successful for 174 (93.5%) women. Reasons for conversion to laparotomy included anticipated technical difficulty (n = 7) and malignancy (n = 5). No intraoperative complications occurred in the entire study group.
Conclusions The vast majority of large adnexal masses can be safely resected laparoscopically, provided that there is expertise in laparoscopic surgery, immediate access to frozen section diagnosis, and preparation of patient to receive an adequate cancer surgery where indicated.
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From October 2002 to October 2007, all women evaluated for an adnexal mass of at least 10 cm in diameter at two referring academic institutions were candidates for laparoscopic management. All women had either a preoperative ultrasound examination or abdominal and pelvic computed tomography scan. Women were excluded from the study if there was an evidence of ascites or gross metastatic disease based on the preoperative imaging studies and if the woman had undergone previous abdominal surgery for malignancies. The presence of a minimal free fluid in the pouch of Douglas was not considered a contraindication for laparoscopy.
No woman was selected for open approach for reasons of mass size, obesity, previous abdominal surgery for benign disease, anticipated difficulty of resection, or suspicion of malignancy. Neither the sonographic features of the cyst nor elevated serum CA125 level was used to exclude women from having a laparoscopic approach.
All procedures were performed by two surgeons (F.G. and V.B.) with extensive training and experience in advanced laparoscopic procedures and in gynaecological oncology. Written informed consent was obtained from the women after a thorough counselling, detailing therapeutic options, risks of the procedure, and the need for possible laparotomy or other indicated procedures. Institutional Review Board approval was obtained before the beginning of the study.
A single protocol was followed for all women. After pneumoperitoneum was created, a 10-mm laparoscope (Karl Storz, Tuttlingen, Germany) was placed either directly or by open technique at the umbilicus. Upon visualising the abdomen and pelvis, any fluid was aspirated and sent for cytological examination. If no fluid was present, peritoneal washings were taken from the cul-de-sac and submitted for cytology. Next, under direct visualisation, two or three 5-mm ancillary trocars were inserted in the lower abdomen. A thorough evaluation of the pelvis and the abdomen, including peritoneal surfaces, omentum, paracolic gutters, liver, and diaphragm was made.
At this point, possibility for the intact, complete removal of the mass and placement in an endoscopic bag with an opening diameter of 12.7 cm (Endo Catch II; Tyco Healthcare Group LP, Norwalk, CT, USA) to accomplish drainage of the cyst within the specimen pouch was assessed. For very large masses, intrabdominal cystic drainage was necessary and a 5-mm trocar with sleeve was inserted as close as possible to the dome of the mass under laparoscopic visualisation. The trocar was removed and the suction-washing system was inserted into the mass through the sleeve. The mass was drained as much as possible and the sleeve was removed. The puncture site in the mass was immediately closed with a prefabricated endoscopic loop tie used to avoid spillage. The procedures involved cystectomy or oophorectomy depending on the patient’s age, the mass size, and suspicious appearance on imaging studies. All adnexal masses were placed into retrieval bags and subsequently removed either through one of the lower quadrant incisions following a small extension, or through the umbilical port, or through a posterior colpotomy incision, as previously reported.14,15 All specimens were sent for immediate pathological evaluation, and management decisions were dependent on the frozen section findings. In the event of malignancy, starting in January 2003, comprehensive surgical staging of apparent early-stage ovarian cancer was carried out laparoscopically, as previously described.16 Before that time period women diagnosed with an apparent stage I ovarian cancer underwent surgical staging through laparotomy. In those cases with macroscopic evidence of extraovarian disease on laparoscopic inspection or on the basis of frozen section findings, cytoreductive surgery was always accomplished by immediate laparotomy. At the conclusion of each case, haemostasis was assured, ancillary accesses enlarged to more than 10 mm for specimen retrieval were closed in layers, whereas the umbilical incision and 5-mm ports had only skin closure.
Demographics, indication for surgery, type of procedure, intraoperative and postoperative complications, conversions, pathological findings, and length of stay were recorded in a prospectively maintained database. Mass size was defined as its largest diameter determined by preoperative imaging studies. Operative time was defined as the time from skin incision to skin closure. Blood loss was estimated from that collected in the suction device. Spillage was defined as any rupture of the tumour capsule, intentional or unintentional, potentially resulting in spill of cyst contents into the peritoneal cavity. If a mass was drained intentionally within a collection bag without a resulting peritoneal spill, the mass was not considered ruptured.
Statistical analysis was performed with GraphPad version 4.00 for Windows (GraphPad Software, San Diego, CA, USA). Normality testing (Kolmogorov–Smirnov test) was performed to determine whether data were sampled from a Gaussian distribution. The t test and the Mann–Whitney U test were performed to compare continuous parametric and nonparametric variables, respectively. Kruskal–Wallis test was used to compare three or more groups. Fisher’s exact test was used to analyse proportions. Statistical significance was considered achieved when P value was less than 0.05.
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During the study period, 186 women met the inclusion criteria and had laparoscopic management of an adnexal mass of 10 cm or larger in size. The median age of patients and body mass index of the study population were 39 years (12–83 years) and 23.1 kg/m2 (17.3–33.6 kg/m2), respectively. Thirty-five percent (65/186) of women were postmenopausal. Thirty-one percent (58/186) of women had previously undergone abdominal surgery for benign diseases, with a median number of prior procedures of 1 (range 1–4). The average preoperative mass size was 12.1 ± 4.9 cm. Ninety-one percent (169/186) of adnexal masses were less than 20 cm, 7% (13/186) were between 20 and 30 cm, and 2% (4/186) had a diameter more than 30 cm.
Intraoperative details and type of procedure are listed in Table 1. Laparoscopic management was successful for 174 (93.5%) women. No complications related to Veress needle or trocars placement occurred. There were 12 (6.4%) conversions to laparotomy: 7 cases were converted electively before removal of the mass due to anticipated technical difficulties with extensive adhesions (1 of whom was ultimately diagnosed with a malignancy) and 5 cases were converted based on frozen section reports indicating a malignancy. Of the women undergoing conversion to laparotomy after frozen section findings, two had evidence of extraovarian disease on laparoscopic inspection and required laparotomy for cytoreduction and three, whose cancer was apparently limited to the ovary, underwent surgical staging by immediate laparotomy, as these cases occurred before introduction of laparoscopic management of early ovarian cancer at our institutions. No intraoperative complications occurred in the entire study group. Tumour spillage occurred in 121 (65.0%) women.
Table 1. Operative details
| ||n = 186|
|Operative time (minutes)—entire group||50 (20–465)|
|Operative time (minutes)—benign disease||50 (20–200)|
|Operative time (minutes)—malignant disease*||120 (30–465)|
|Estimated blood loss (ml)||22 (0–2000)|
|Monolateral salpingo-oophorectomy||46 (24.7)|
|TLH and BSO||6 (3.2)|
|TLH, BSO, omentectomy, and appendicectomy||2 (1.1)|
|Comprehensive surgical staging||14 (7.5)|
|TAH, BSO, and cytoreductive surgery||2 (1.1)|
The distribution of pathology findings is listed in detail in Table 2. Diagnosis by frozen section was in agreement with that of permanent section in all cases. A benign pathological condition was found in 86.6% (161/186) of the women. Frozen section showed primary ovarian cancer in 16 (8.6%) women, a metastatic tumour of gastrointestinal origin in 1 (0.5%) woman, and a low malignant potential (LMP) ovarian tumour in 8 (4.3%) women. The median (range) size of benign, LMP, and malignant masses was 10 cm (10–36 cm), 22.5 cm (10–40 cm), and 10.2 cm (10–28 cm), respectively. No significant difference was found in tumour size between the malignant and benign groups, while borderline tumours were significantly larger than benign masses (P = 0.01). The median (range) mass size was similar between premenopausal and postmenopausal women (10 cm [10–40 cm] versus 10 cm [10–26 cm], P = 0.38). The proportion of malignant tumour was 6/120 (5.0%) in premenopausal women and 11/65 (16.9%) in postmenopausal women (P = 0.01).
Table 2. Histopathological findings of the study population
|Histopathological diagnosis||n = 186|
|Endometriotic cyst||35 (18.8)|
|Dermoid cyst||37 (19.9)|
|Serous cystoadenoma||39 (21.0)|
|Mucinous cystoadenoma||25 (13.4)|
|Benign epithelial-lined cyst||16 (8.6)|
|Functional cysts||3 (1.6)|
|LMP tumour||8 (4.3)|
|Malignant epithelial tumours|
|Clear cell||1 (0.5)|
|Granulosa cell tumour||1 (0.5)|
|Metastatic tumour||1 (0.5)|
The preoperative characteristics, pathological findings, stage, and follow up of women ultimately found to have ovarian cancer are listed in Table 3. Among women with ovarian cancer apparently limited to the ovary (n = 14), 10 had comprehensive surgical staging entirely by laparoscopy. The median operative time of laparoscopically managed ovarian cancer was 375 minutes (range 220–465 minutes). A young woman with ovarian dysgerminoma underwent a laparoscopic fertility-sparing procedure. Three women managed by laparoscopic approach and two undergoing open surgery had an upstaging of their supposed stage I ovarian cancer.
Table 3. Preoperative characteristics, pathological findings, stage, and follow up of women with a large adnexal mass, ultimately found to have ovarian cancer
|Patient||Serum CA125 level (mIU/ml)||Suspicious appearance on preoperative imaging studies*||Histological cell type||Stage||Grade||Conversion to laparotomy||Follow-up time (months)||Follow-up outcome|
Adjuvant chemotherapy with a combination of carboplatin and paclitaxel was administered to 13 of 16 women with ovarian cancer. Two women with stage IIIC disease, one managed laparoscopically and one undergoing conversion to laparotomy, had intraperitoneal recurrence and died of disease 8 and 16 months after surgery, respectively. The first patient received a cycle of second-line salvage chemotherapy with ifosfamide after the diagnosis of recurrence, the latter underwent secondary debulking surgery with small bowel resection and palliative ileostomy 12 months after primary surgery.
All LMP tumours were managed laparoscopically and five of eight (62.5%) women underwent fertility-sparing procedures. All women diagnosed with LMP tumour are alive with no evidence of disease after a median follow up of 17.5 months (range 1–35 months).
Minor postoperative complications occurred in three of laparoscopically managed cases and included two patients with febrile morbidity, that required in one case antibiotics and one umbilical port site infection, that healed well after conservative measures. The median length of hospital stay was 1 day (range 1–3 days) and 4 days (3–9 days) for women who underwent laparoscopy and for those converted to laparotomy, respectively.
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Our findings suggest that a laparoscopic approach is feasible and beneficial to a large proportion of women with a large adnexal mass if performed appropriately and by experienced hands.
A MEDLINE search of the English language literature from January 1995 to October 2007, using as search terms ‘large’, ‘huge’, ‘giant’, ‘size’, ‘adnexal mass’, ‘ovarian cysts’, ‘ovarian tumour’, and ‘laparoscopy’ alone or in combination, after exclusion of single case reports, identified seven cohort studies,3–9 involving a total of 124 women, that specifically address the outcome of laparoscopic resection of large adnexal masses (Table 4).
Table 4. Studies on laparoscopic management of large adnexal masses
|Reference||Cases (n)||Size (cm)||Technique||Procedure||Operative time (minutes)||Blood loss (ml)||Intraoperative or postoperative complications||Conversion to laparotomy||Reported intraoperative tumour rupture rate (%)*||Malignant tumours|
|Ou et al.3||18||≥10||Cysts above the umbilicus: aspiration through paraumbilical mini-laparotomy. Cysts below the umbilicus: aspiration within endobag; purse string suture to secure the cystic wall around the aspiration needle||Cystectomy (n = 5), oophorectomy (n = 10), SO (n = 2)||N.A.||97 (50–200)||0||0||22.2||1 (5.6%)|
|Salem4||15||Above umbilicus||Puncture with a 5-mm trocar||Cystectomy||53.7 ± 14.7||N.A.||0||0||100||0|
|Ma et al.5||3||25 (20–40)||Puncture with a 5-mm trocar||Oophorectomy (n = 1), SO (n = 2)||95 (90–130)||50 (10–80)||0||0||100||2 (66.7%) LMP|
|Sagiv et al.6||21||Above umbilicus||Aspiration of fluid content and use of special removal bags||Cystectomy (n = 8), oophorectomy (n = 13)||95 ± 26||N.A.||0||One malignancy, one technical difficulty||100||1 (4.8%)|
|Goh et al.7||4||21 (20–25)||Laparoscopic-guided aspiration and extracorporeal cystectomy||Cystectomy||N.A.||N.A.||One postoperative transfusion||0||100||0|
|Benedetti Panici et al.8||30||8.4 (8–12.2)**||Aspiration within endobags. For larger masses, intrabdominal puncture with a 5-mm trocar||Cystectomy||81 (45–124)||N.A.||0||One malignancy, five technical difficulty||87||1 (3.3%)|
|Eltabbakh et al.9||33||13 (10–22)||Laparoscopic-guided aspiration with a Bonanno suprapubic catheter||Cystectomy (n = 4), SO (n = 29)||80 (45–125)||89 (20–250)||0||Two technical difficulty||100||2 (6.1%) LMP|
|Current study||186||10 (10–40)||Aspiration within endobags. For larger masses, laparoscopic-guided aspiration with a 5-mm trocar and closure of the puncture site with an endoloop||Cystectomy (n = 83), SO (n = 103)||50 (20–465)||22 (0–2000)||Three minor postoperative complications||Five malignancy, seven technical difficulty||65||17 invasive cancer, 8 LMP, total = 25 (13.4%)|
The present investigation involves the largest series of consecutive women undergoing laparoscopic treatment for a large ovarian mass. The minimal access approach has not been uniformly accepted as appropriate for the management of large ovarian tumours due to concerns of malignancy and case complexity. The risk of encountering a malignant ovarian tumour is the most often cited reason for restricting laparoscopic approach to adnexal masses smaller than 10 cm in size. Although the size of an adnexal mass has been shown to be an independent predictor of the risk of its being malignant,17 many, if not most, large ovarian tumours are benign. In a prospective study involving a cohort of 1304 women with unilocular cysts operated over a 10-year period, the frequency of benign pathology was identified in 93.2% of cases among masses of 8 cm or larger.18 In a review of 1648 histopathologically diagnosed ovarian masses, benign pathology was discovered in 68% of cysts between 10 and 19 cm in size, and in 48% of cysts with a diameter of 20 cm or more.19 Childers et al.20 in a study addressing laparoscopic management of suspicious adnexal masses (elevated CA125 and/or masses that did not meet ultrasound criteria for benignity, including size <10 cm) found a benign pathological condition in 86% (119/138) of the study population and in 79.2% (38/48) of the women with a mass more than 10 cm in diameter.
Evidence from several studies suggests that specificity of frozen sections is consistently high in all size categories of adnexal tumours, whereas sensitivity is particularly reduced in large tumours, especially with mucinous histology.21 Under these circumstances, a laparoscopic approach for primary surgery in women with a large mass later proved malignant may help decrease the likelihood of subjecting understaged women to a relaparotomy, which can ultimately translate in a significantly higher morbidity. The availability of specialised pathologists in both institutions and performance of multiple slices in large masses could have contributed to the high accuracy of frozen section diagnosis in our study group.22
Data from published series indicate that for women with large adnexal masses, nearly 10 abdominal surgeries have to be performed to remove one ovarian cancer, even without attempts of preselection for benign pathology.3–9,20 If size is the sole criterion on which the operative approach is based, many women with large benign tumours will have an unnecessary laparotomy and will not experience the known benefits that minimal access surgery has afforded to women with smaller tumours. If we had strictly followed a 10-cm threshold for performing open surgeries, 155 of 161 women with benign adnexal masses in our cohort would have undergone midline laparotomy when their mass could have been successfully resected laparoscopically.
The higher rate of capsular rupture is another reason for the vilification of laparoscopy in the setting of large adnexal masses. Minimal access surgery is more likely than laparotomy to result in capsular rupture because large tumours often require drainage before removal either to allow specimen retrieval or to achieve adequate working space. The reported incidence of tumour spillage in published series of laparoscopically managed large adnexal masses varies between 22 and 100%, probably reflecting differences in the definition of spillage rather than in surgical technique.3–9 The term spillage should refer to any transgression of the tumour capsule during operative removal whether accidental, unavoidable or by design. Some investigators do not consider spillage intentional needle aspiration during surgery unless in the surgeon’s judgement, the whole peritoneal cavity has been soiled in the process. Moreover, distinction between tumour rupture and puncture is not detailed in most studies. Advocates of open approach for large adnexal masses raise the continuing controversy about the prognostic value of malignant mass rupture. If we look at the literature about capsular rupture, all articles are retrospective studies, comprising women without comprehensive staging and who may or may not have received adjuvant therapy, and only the most recent ones include a multivariate analysis. Moreover, in some reports, laparoscopic capsular rupture was followed by a delay in definitive surgery that could theoretically have contributed to recurrence. The prognostic value of malignant mass rupture was emphasised by Vergote et al.23 in a review of six international databases, including 1545 women who underwent laparotomy for early ovarian cancer. Surgical rupture of the tumour was found to be an independent predictor of disease-free survival. The retrospective nature of this survey carries all the inherent potential drawbacks of this study design. Unrecognised factors that could have contributed to differences in the measured outcome include peritoneal washing not routinely performed, lymph node sampling rather than systematic lymphadenectomy, and no distinction between tumour rupture and puncture. No prospective comparative data support the existence of an increased tumour spillage in women with ovarian cancer managed by laparoscopic techniques, and unequivocal evidence that cyst rupture in early ovarian cancer worsens the prognosis is lacking. Opponents of minimally access surgery also claim that, whether women whose malignant masses rupture intraoperatively have higher recurrence rates or not, the standard of care dictates that these women should receive adjuvant chemotherapy, which significantly affects quality of life. However, in the event of an unexpected malignancy, regardless of upstaging for tumour rupture, the likelihood that a woman will be spared chemotherapy is low because surgical treatment alone is considered curative only for stage Ia or Ib with grade I disease and histotype other than clear cell,24 that is a very small proportion of women with ovarian cancer.
A recent randomised trial laparoscopy versus laparoscopic-guided mini-laparotomy for the management of large adnexal masses found a relative risk of cyst rupture among women undergoing laparoscopy compared with those treated with mini-laparotomy of 5.5.8 However, the mean diameter of the masses was approximately 8 cm in both groups, and cysts exceeding 18 cm in size were excluded. Thus, whether these results can be held true also for larger masses that invariably require decompression to be removed, even through a small laparotomic incision, needs to be determined. We feel that tumour spillage is a serious concern but not sufficient justification for recommending open surgery for all women with a large ovarian cyst, provided that the intent of gynaecological cancer surgery are not sacrificed for the benefits of laparoscopy.
Clearly, taken together without reliable criteria to differentiate benign and malignant masses preoperatively and uncertainty on prognostic harmlessness of capsular rupture, it is prudent to approach all large adnexal masses as if they are malignant tumour. Therefore, we suggest that some basic requirements are needed for consideration for laparoscopic management of a large adnexal mass: (1) absence of ascites or gross metastatic disease and a not purely solid mass requiring morcellation outside an endobag as a result of size; (2) availability of a gynaecologic oncologist and plan in place for appropriate staging at the same procedure; (3) operating surgeon both knowledgeable and skilled in advanced laparoscopic surgery; (4) use of expert frozen section for critical decision-making; (5) strict intraoperative protocols entailing puncture of the mass within an endoscopic bag whenever possible or under laparoscopic visualisation for very large tumours, minimising spill of cyst content into the peritoneal cavity and immediate closure of the puncture site.
At a time when laparoscopy is increasingly being adopted for the management of women with early ovarian cancer, a rethinking of firm criteria for women who undergo laparoscopy for adnexal masses seems mandatory. The general feasibility of laparoscopic management of suspicious adnexal masses has been clearly demonstrated in previously published series, dating back to the 1990s.20,25 When a malignancy is encountered, we feel that the primary issue is the appropriate management of the patient, with definitive resection and staging at the same procedure, not whether laparoscopy or laparotomy is used. Since laparoscopy is no longer synonymous with ovarian cancer mismanagement, concerns of tumour rupture and inadequate staging should not be used as arguments against a minimal access approach to large ovarian cysts, provided that surgeons with skills in advanced laparoscopic procedures are available and appropriate safety measures are adopted. Besides sparing patients unnecessary laparotomies for diagnosis, minimal access approach can be employed for comprehensive surgical staging,15,26–28 without violating the intent of gynaecological cancer surgery. We acknowledge that at present, objective evidence of equivalency between laparoscopy and the established standard of care for early ovarian cancer in terms of overall and disease-free survival is lacking. As stage I ovarian cancer is a rare condition, large-scale randomised controlled trials to validate the benefits of laparoscopy over open surgery for the management of early ovarian cancer are currently lacking and unpractical to accomplish. In the absence of large-scale randomised controlled trials to validate the benefits of laparoscopy over open surgery for the management of early ovarian cancer, we must rely on nonrandomised case–control studies17,26 and a retrospective multicentre comparative survey29 in the recent literature aimed at assessing the impact of initial surgical access on survival. These data suggest that laparoscopic staging is as adequate as staging through laparotomy in terms of nodes yield, omental size, and likelihood of identification of metastatic disease. Tozzi et al.28 have reported the longest follow up to date of laparoscopically managed early ovarian cancer. In their prospective study of 24 women with a median follow-up time of 46 months, overall and disease-free survival were 100% and 92%, respectively.
Sceptics of the use of laparoscopy for the treatment of ovarian cancer can also be concerned with prolonged operative times. Our average procedure time of about 6 hours in laparoscopically managed ovarian cancer is quite long, although consistent with other published series.26,28 Although we did not calculate operative time of each phase of the procedure independently, the most time-consuming procedure is obviously lymphadenectomy, particularly the para-aortic lymphadenectomy phase that is characterised by a steep learning curve.
The current study adds to a limited literature suggesting that, when the surgeon acquires an appropriate level of experience, the majority of large adnexal tumours can be safely resected laparoscopically. The most important variable in terms of choosing a laparoscopic or open approach may not be the mass size, but the experience of operating team, immediate access to accurate frozen section diagnosis, and preparation of patient to receive an adequate cancer surgery if indicated.