Horizontal versus vertical direction of posterior vaginal wall suture after eradication of rectovaginal endometriosis: A multicenter study

To compare safety and effectiveness of two‐different directions of suturing the posterior vaginal breach (horizontal [Ho] vs vertical [Ve]) in women undergoing recto‐vaginal endometriosis (RVE) nodule resection.


| INTRODUC TI ON
Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity. 1 It represents an important cause of morbidity in reproductive-aged women, resulting in pelvic pain, pelvic masses and infertility. 2,35][6][7] Vaginal endometriosis is defined as infiltration of the vaginal wall by endometrial stroma and glands.It can be isolated or involving adjacent structures, especially the recto-sigmoid tract (recto-vaginal endometriosis [RVE]). 4,80][11] While hormonal therapy can improve pain symptoms in 30% of women with RVE, surgical eradication is required in cases of nonrespondent women, bowel or urinary obstruction, or infertility after assisted reproductive technology attempts. 6,7,12Moreover, RVE surgical eradication needing partial colpectomy is commonly associated with a high risk of major postoperative complications, especially urinary and colorectal ones. 13,14[16][17][18][19] Conversely, in patients affected by RVE, there is no evidence about what is the best direction in suturing the posterior vaginal fornix defect after the nodule resection: horizontal (i.e., along the transversal latero-lateral axis; Ho) versus vertical (i.e., along the longitudinal ventro-caudal axis; Ve).Therefore, in the present study, we sought to compare safety and effectiveness in terms of pain and anatomical recurrence of the two different directions of suturing the posterior vaginal breach in women affected by symptomatic RVE with vaginal mucosa infiltration and scheduled for minimally invasive surgery.

| Study protocol and patient selection
This multicenter, observational, retrospective, cohort study was designed according to an a priori defined study protocol.The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines and checklist were followed for reporting the whole study. 20e medical records and clinical electronic databases were reviewed for all consecutive women of reproductive age who un- The patients were divided into two groups based on the direction in suturing the posterior vaginal fornix defect after the nodule resection (Ho-group vs Ve-group) for comparisons in terms of postoperative data.In particular, in case of vertical suture vaginal synthesis was done through vaginal approximation, while in case of horizontal one vagina was sutured to the cervix.

| Study outcomes
Study outcomes consisted of the differences in postoperative data between the Ho-group and the Ve-group.In particular, postoperative data assessed were rate of postoperative complications occurring within 30 days from surgery, length of hospital stay, pain relief, and pain and anatomical recurrence.In detail, pain recurrence was defined as reappearance of at least one mild-severe pain symptom, while anatomical recurrence was defined as reappearance of an endometriotic lesion at imaging or clinical evaluation or diagnostic evaluation/pathologic examination after secondary surgical excision.

| Patient management
Before surgery, demographic features and pain symptoms (chronic pelvic pain, dysmenorrhea, deep dyspareunia, dysuria, dyschezia) were assessed.The severity of the pain was evaluated using a 11point numerical rating scale (NRS) and considered "severe" when a value equal to or higher than 5 was noted. 21l women underwent bimanual and speculum examinations as well as transvaginal and transabdominal ultrasonography performed by skilled operators.When necessary, additional preoperative imaging methods, including multi-detector computerized tomography enteroclysis, urography or magnetic resonance imaging, were performed to plan surgery. 224][25] After total laparoscopic or vaginallyassisted laparoscopic (i.e., combined vaginal approach) removal of the vaginal nodule, the vaginal breach was sutured in Ho or Ve direction with an absorbable thread specifically polyglactin 910 (Vicryl; Ethicon). 26,27The suturing direction performed was chosen on a case by case basis according to the surgeon's intraoperative choice.
In particular, the suture used upon physician preference was preferentially continuous when performed vaginally and interrupted when performed laparoscopically.
Endometriosis was classified according to the revised American Society for Reproductive Medicine (rASRM) classification. 28stoperative complications were assessed using Clavien-Dindo classification. 29r each patient, pain scores and surgical complications were evaluated at the last follow-up evaluation.

| Statistical analysis
Continuous data are expressed as mean ± standard deviation (SD) or as median and range.Categorical variables are expressed as absolute numbers and percentages.Univariate comparisons were performed adopting the t test or the Mann-Whitney test for continuous data and the chi-square test or the Fisher exact test for categorical data.All reported P values were two-sided, and a P value of less than 0.05 denoted a statistically significant difference.
Statistical analysis was carried out using the Statistical Package for the Social Sciences (SPSS) software version 24.0 (IBM Corp.).

| Ethical statement
The study was carried out according to the principles of the Helsinki Declaration and received approval by Institutional Review Board (INTRAMURAL ID: CICOG-31-10-18/180).
Written informed consent was obtained from all the subjects in the study and all data were anonymized.

| Study groups
During the study period, 101 women who met the selection criteria were included in the study: 67 (66.3%) in the Ho-group and 34 (33.7%) in the Ve-group.
Pathology confirmed endometriosis in all women.The two groups were comparable in terms of demographic and preoperative clinical data (Table 1).
The surgical details are reported in Table 2.The two groups were similar in terms of operative time, estimated blood loss, laparotomic conversion rate and concomitant procedures.The combined vaginal approach excision, which consists of the incision and isolation of the vaginal nodule through a vaginal approach before laparoscopic entry, was more common in the Ho-group than in the Ve-group (38.8% vs 8.8% P = 0.002). 11The mean size of the removed vaginal nodule was 2.2 ± 1.1 versus 2.4 ± 1.1 cm, with no significant difference between the two groups (P = 0.62).

TA B L E 1
Preoperative data of the study groups: Ho-group (Ho) and Ve-group (Ve).The length of hospital stay did not significantly differ between the groups (6.7 ± 6.9 vs 6.6 ± 3.3 days; P = 0.95).

| DISCUSS ION
The present study showed that in women who undergo minimally invasive RVE nodule resection, suturing the posterior vaginal fornix defect in a horizontal direction may be more commonly associated with severe postoperative complications and worse pain control at long-term follow-up evaluation.On the other hand, overall postoperative complications and recurrence rates appear similar.Symptom relapses are often associated with anatomical recurrence, which is not always detectable with gynecological examination, instrumental tools or re-surgery. 30E surgical eradication needing partial colpectomy is a challenging surgery, with a high risk of major postoperative complications, particularly urinary and colorectal. 13,1416][17]31 A total laparoscopic approach can be performed using a traditional or reverse technique. 14 These results are in contrast with the findings of Zanetti-Dallenbach et al. who concluded that the combined approach for RVE and rectal nodule removal significantly decreased hospitalization time, and complication and re-hospitalization rates. 9In a retrospective, comparative study, Roman et al. assessed that the combined approach for large RVE could reduce the risk of postoperative bladder atony probably due to a better preservation of the pelvic splanchnic nerves. 31However, postoperative bladder dysfunction rates vary in the literature and depend on several factors, such as endometriotic infiltration of the lateral and posterior parametria and relative surgical procedures on the parametria. 33teworthy, while several studies assessed different surgical routes for RVE excision, direction in suturing the posterior vaginal fornix defect after the nodule resection has been poorly investigated.
In our study, we found a higher rate of severe postoperative complications and worse pain control in women who underwent suturing of the posterior vaginal fornix defect in a horizontal direction after RVE nodule resection.These findings might be explained by stronger tension forces on the stitches due to a reduction of length of the vagina.In fact, a shorter vaginal length (median loss of 10% of length) appeared to be associated with horizontal sutures in a recent meta-analysis of five randomized trials including TA B L E 3 Postoperative data of the study groups: Ho-group (Ho) and Ve-group (Ve).

Ho (67) Ve (34) P value
[36][37][38][39] Furthermore, a possible shorter vaginal length might also underlie the better clinical outcomes of the Ve-group.Indeed, in a randomized clinical trial assessing the effect of hysterectomy for several pathologies on lower urinary tract function, vaginal length, and dyspareunia, Polat et al. reported that patients who developed postoperative dyspareunia had a significant shortening of total vaginal length after colpotomy. 40nversely, in reference to the radicality of the surgery, direction of suturing appeared not differ in the outcomes.In fact, as we found no significant difference in terms of RVE relapse in the two study groups, the two techniques did not seem to impact on the persistence of micro or macroscopic ectopic cells residuals.
Moreover, a higher rate of open conversion was observed in the Ho group compared to the Ve group.We reviewed reasons for laparotomy conversions and found that they were related to anesthesiologic reasons (4/67, 6%) and the need for securing blood vessels in case of intractable intraperitoneal hemorrhage (2/67, 3%).In particular, all cases of open conversions occurred after vaginal suture and were not related to the direction of vaginal suture.
However, additional studies are necessary to confirm our findings and further investigate the field.

| Strengths and limitations
To the best of our knowledge, this may be the first study which has evaluated the safety and effectiveness of the two different directions of suturing the posterior vaginal breach in women who undergo minimally invasive RSE nodule resection.Moreover, our results also appear to be supported by a long-term follow-up.
Conversely, some limitations might limit the generalizability of our findings, such as the retrospective study design, different follow-up period between the two groups, the tertiary center setting with experienced surgeons and the possible selection bias due to surgeons' preference for vaginal breach suture direction.Lastly, the absence of data on length of vagina before and after surgery meant we were unable to verify our hypothesis in explaining the difference among the groups.

| CON CLUS ION
In symptomatic women affected by RVE with vaginal mucosal infiltration requiring surgery, horizontal suturing of the vaginal breach after nodule resection seems to be more commonly associated with severe postoperative complications and worse pain control.
Further studies are needed to confirm these findings.
derwent minimally invasive complete macroscopic eradication for symptomatic RVE with vaginal mucosa infiltration between March 2013 and December 2018 at the Department of Gynecologic Onocology, Gemelli Molise SpA, Campobasso, Italy; the Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; and the Division of Gynecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.Exclusion criteria were: (1) women <18 and >50 years; (2) history of RVE surgical treatment or hysterectomy; (3) previous or ongoing oncological gynecologic diseases.