VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy.

INTRODUCTION: Hysterectomy is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal hysterectomy. Hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). METHODS: Multicentre pragmatic RCT aiming to recruit 1000 women aged 18-75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH is considered safe and feasible, the patient will be randomised within group A (VH vs vNOTES). If VH is not considered safe or feasible, patients will be randomised within group B (LH vs vNOTES). ANALYSIS: Primary outcome is the proportion of women leaving the hospital within 12 hours after surgery. Secondary outcomes are hospitalisation time, conversion rates, duration of the surgical procedure, intraoperative complications, postoperative complications and readmission. ETHICS AND DISSEMINATION: The Ethical Board Committee at Imelda Hospital, Bonheiden, Belgium, has approved the research protocol 230704 (principal investigator). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05971875.

Comparison of hysterectomy cases performed by transvaginal natural orifice transluminal endoscopic surgery: A paired sample cross-sectional study.

This study aimed to investigate the feasibility, indications, and benefits of transvaginal natural orifice transluminal endoscopic surgery (v-NOTES) hysterectomy for nonmalignant gynecological diseases. The clinical data, including the baseline information and surgical conditions of 81 patients who underwent v-NOTES hysterectomy for nonmalignant gynecological diseases in a tertiary university hospital from October 2018 to August 2022, were retrospectively analyzed and compared with the total laparoscopic hysterectomy group (200 cases) and the transumbilical laparoendoscopic Single Site Surgery group (150 cases). In comparison with the other 2 groups, the highest proportion of patients in the v-NOTES group had cervical intraepithelial neoplasia. Accordingly, mean preoperative uterine volume measured by sonography was significantly smaller in the v-notes group. In the v-NOTES group, the mean number of vaginal deliveries and age were significantly higher, while the mean number of previous abdominal surgeries was lower compared to the other 2 groups. The V-NOTES group had a shorter operation time, shorter postoperative urinary catheter insertion time, earlier intestinal recovery days, shorter hospital stay, and lower visual analogue scale scores after surgery, and the differences were statistically significant. When indicated appropriately, v-NOTES hysterectomy can be a feasible and advantageous surgical modality. In particular, in comparison to the laparoendoscopic Single Site Surgery and total laparoscopic hysterectomy groups, the v-NOTES group had advantages in postoperative recovery and had more aesthetic surgical results.

Colporrhaphies versus Colpocleisis Following Vaginal Hysterectomy for the Treatment of Advanced Pelvic Organ Prolapse: A Comparative Study.

BACKGROUND: Obliterative vaginal procedures may offer lower perioperative morbidity and equal success rates as reconstructive procedures for frail and elderly women who no longer desire future coital function. The combination of vaginal hysterectomy with either reconstructive or obliterative vaginal procedures has not yet been investigated. OBJECTIVES: To compare peri- and postoperative outcomes of vaginal hysterectomy with pelvic floor reconstruction (VHR) vs. vaginal hysterectomy with colpocleisis (VHC). METHODS: We conducted a retrospective study comparing medical and surgical data of patients undergoing either VHR or VHC between 2006 and 2015. Data were obtained from inpatient and outpatient medical records including peri- and postoperative course, as well as long-term (24 months) follow-up data. RESULTS: We identified 172 patients who underwent VHR and 44 who underwent VHC. Patients in the VHC group were significantly older (71.3 ± 4.5 vs. 68.6 ± 6.5 years, P = 0.01), and more likely to have medical co-morbidities (P = 0.001 and P = 0.029, respectively). Patients in the VHC group experienced shorter operative time (2.3 ± 0.58 vs. 2.7 ± 1.02 hours, P = 0.007), lower perioperative blood loss (P < 0.0001), shorter hospital stay (P < 0.0001), and lower rates of postoperative urinary retention. Long-term pelvic organ prolapse (POP) recurrence rates were significantly higher among the VHR group. Postoperative resolution of both stress urinary incontinence and overactive bladder were common in both groups. CONCLUSIONS: VHC is associated with lower perioperative blood loss, shorter operative time, shorter hospital stay, shorter time with an indwelling catheter, and lower long-term objective POP recurrence rates.

Comparison of survival outcome of open, total laparoscopic, and laparoscopy-assisted radical vaginal hysterectomy for stage IB2 cervical cancer patients: A multicenter retrospective study.

The aim of this study was to compare survival outcomes of 3 different radical hysterectomy (RH) types, namely total abdominal radical hysterectomy (TARH), total laparoscopic radical hysterectomy (TLRH), and laparoscopy-assisted radical vaginal hysterectomy (LARVH), in patients with FIGO stage IB2 cervical cancer. We retrospectively identified a cohort of patients who underwent RH for cervical cancer between 2010 and 2017. Patients with stage IB2 cervical cancer were included and were classified into TARH, TLRH, and LARVH treatment groups. Survival outcomes were estimated by the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazards models were fit to estimate the independent association of RH technique with outcome. 194 patients were included in this study: 79 patients in the TARH group, 55 in the TLRH group, and 60 in the LARVH group. No significant differences were found in clinicopathological characteristics between the 3 RH groups. On comparing survival outcomes with TARH, both TLRH and LARVH showed no significant difference in terms of 5-year overall survival (TARH vs TLRH, P = .121 and TARH vs LARVH, P = .436). Conversely, compared to the TARH group, 5-year progression-free survival (PFS) was significantly worse in the TLRH group (P = .034) but not in the LARVH group (P = .288). Multivariate analysis showed that TLRH surgical approach (hazard ratio, 3.232; 95% confidence interval, 1.238-8.438; P = .017) was an independent prognostic factor for PFS in patients with IB2 cervical cancer. Our study suggests that in patients with FIGO stage IB2 cervical cancer, among the minimally invasive RH approaches, TLRH and LARVH, only TLRH approach was associated with worse PFS when compared with the TARH approach.

Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.

Impact of Mannitol Bladder Distension in the Intraoperative Detection of Ureteral Kinking During Pelvic Floor Surgery.

INTRODUCTION AND HYPOTHESIS: Ureteral injuries are the most feared complications of gynecological surgery and therefore intraoperative recognition is of the utmost importance. Intraoperative cystoscopy represents the diagnostics of choice to investigate ureteral patency thanks to the direct visualization of ureteral flows after administration of infusion mediums. In this study, we aimed to compare the diagnostic performance of saline versus mannitol intraoperative cystoscopy in terms of false negatives in a large cohort of patients. METHODS: We retrospectively analyzed data of patients who underwent vaginal hysterectomy and high uterosacral ligament suspension for POP. Patients were divided in two groups based on the use of saline or mannitol medium for intraoperative cystoscopy. Postoperative daily control of serum creatinine was performed until discharge, as well as urinary tract imaging, in symptomatic patients. RESULTS: A total of 925 patients underwent vaginal hysterectomy followed by high USL suspension for POP. Saline and mannitol medium were used in 545 patients and 380 patients respectively. Postoperative ureteral injuries were identified in 12 patients, specifically in 2% of the saline group and in 0.3% of the mannitol group. CONCLUSIONS: The use of mannitol instead of saline as a bladder distension medium was able to significantly reduce the occurrence of postoperative ureteral sequelae.

Summative Evaluation of Vaginal Surgery Skills: Setting A Pass-Fail Score.

INTRODUCTION AND HYPOTHESIS: We developed a summative assessment tool to evaluate competent performance on three procedure-specific low fidelity simulation models for vaginal surgery. Our purpose was to determine a pass-fail score for each model. METHODS: We enrolled participants (2011-2023, three Canadian academic centers) and grouped them according to operative competency in vaginal procedures. Novice operators were medical students recruited through targeted advertisement to clerkship level medical students. Proficient operators consisted of gynecology residents from the intervention arm of a randomized controlled trial, trained to competence in the use of the models; urogynecology fellows and attending gynecologic surgeons recruited through departmental rounds. All participants were asked to perform the three procedures on the models, were videotaped, and their performance assessed by evaluators familiar with the procedure and the scoring system, blinded to operator identity. A total performance score (range 0-400) assessed timing and errors. Basic skill deductions were set a priori. We calculated sensitivity and specificity scores and obtained an optimal cutoff based on Youden's J statistic. RESULTS: For anterior repair, we rated 46 novice and 16 proficient videos. The pass-fail score was 170/400. For posterior repair, we rated 54 novice and 14 proficient videos. The pass-fail score was 140/400. For vaginal hysterectomy, we rated 47 novice and 12 proficient videos. The pass-fail score was 180/400. Scores of proficient operators were significantly better than those of novice participants (p < 0.001 for all). CONCLUSIONS: A pass-fail score can distinguish between novice and proficient operators and can be used for summative assessment of surgical skill.

Reducing patient's perception of postoperative vaginal bleeding after laparoscopic hysterectomy via independent closure of the vaginal cuff angles (RCT).

STUDY OBJECTIVE: Determine if independently suturing the vaginal cuff angles in addition to running barbed suture has an effect on patients' perception of postoperative bleeding after laparoscopic hysterectomy. DESIGN: Randomized controlled trial. SETTING: University-based medical center. PATIENTS: Females ages 18-60 undergoing laparoscopic hysterectomy. INTERVENTIONS: Patients were randomly assigned to either cuff closure via single layer of barbed suture (control) vs adding figure-of-eight stitches at each angle (intervention). A survey was given between 10 and 25 days after surgery inquiring about bleeding and dyspareunia. A second survey was given between postoperative days 90-114. Chart review was performed to record emergency room visits, complications, infections, and reoperations during the first 90 postoperative days. RESULTS: n = 117 patients were analyzed. 62 (control) and 55 (intervention). Groups were similar in terms of age (42.92 v 44.29p =.35), BMI (33.79 v 34.06p =.85), diabetes (5.26 % (3/55) v 15.09 % (8/53) p =.08) p =.97). Bleeding was decreased in intervention arm (24.19 % (15/62) v 9.09 % (5/55) p =.03). Median (IQR) pelvic pain score was similar (2.0 (0-5.0) v 2.0 (0-4.0) p =.26). Median total operative time (IQR) (129 min (102, 166) v 139 min (120, 163) p =.39) and median EBL (IQR) (50 mL (30-75) vs 50 mL (20-75) p =.43) were similar. Cuff closure in seconds (IQR) was higher in intervention group (373 sec (323, 518) v 571 sec (520, 715) p <.01). 8/60 control patients visited the ED (13.33 %) v 7/54 (12.96 %) p =.95. Readmissions (1.67 % (1/60) v 1.85 % (1/55) p = 1), re-operations (0 % (0/60) v 1.85 % (1/55) p =.47) and postoperative infections (5.0 % (3/60) v 1.85 % (1/54) p =.62) were similar. Secondary survey showed no significant difference in bleeding (15.38 % (4/26) v 4.35 % (1/23) p =.35) and SF-36 results were similar. CONCLUSION: Independently suturing the vaginal cuff angles reduces patients' perception of vaginal bleeding in the early postoperative period. Incidence of complications, reoperations, and long-term quality of life are similar.

Central Sensitisation Syndrome: A Frequent Finding in Women with Pelvic Floor Symptoms Without Evident Urogenital Prolapse.

INTRODUCTION AND HYPOTHESIS: Women with central sensitisation syndrome (CSS) experience poorer subjective post-operative outcomes even after successful pelvic floor reconstruction. This study tests the hypothesis that women with pelvic floor symptoms (PFS) without relevant pelvic organ prolapse (POP), are more likely to have CSS. METHODS: A questionnaire was sent to women who participated in the POP-UP study in 2017. The POP-UP study evaluated POP in 247 women 16 years after laparoscopic or vaginal hysterectomy. POP-Q data and Pelvic Floor Distress Inventory (PFDI-20) results were used and supplemented with CSS-specific questionnaires. A Central Sensitisation Inventory (CSI) score above 40 implicates CSS. Women were divided into groups based on POP beyond the hymen in relation to the PFDI-20 score. Outcomes of women with PFS and without POP (called 'group 1') were compared with the rest of the cohort (groups 2-4; women without PFS and/or with POP). RESULTS: A total of 136 women were included in the analysis. A CSI score above 40 was present in 16 out of 42 women of group 1 (37%) versus 11 out of 93 women of groups 2-4 (12%), p < 0.0001. Passive coping was more prevalent in group 1 (p = 0.039), and more deviations in somatisation, depression, anxiety and distress were found in group 1 (p values of < 0.0001, 0.018, 0.003 and 0.002 respectively). CONCLUSIONS: This study suggests that CSS might be more prevalent in women with PFS without relevant POP. More awareness of CSS and valid individual counselling may overcome unnecessary surgery for POP and help in setting realistic expectations.

Long-term risk of adnexal operation after vaginal hysterectomy for pelvic organs prolapse repair.

OBJECTIVE: To determine if women who undergo vaginal hysterectomy for pelvic floor prolapse repair without concomitant opportunistic bilateral salpingo-oophorectomy are at increased risk of further complications related to the remaining adnexa later in life. STUDY DESIGN: The database of a tertiary university medical center was searched for all women who underwent vaginal hysterectomy as part of the treatment for pelvic organ prolapse, without opportunistic adnexectomy, from 2006 to 2015 to provide adequate time for long-term evaluation. Demographic and clinical data including surgeries performed during the long-term follow-up were collected from all medical insurer electronic medical records. RESULTS: The cohort included 427 women of mean age 63 ± 9.3 years; 90.9 % were postmenopausal. Mean duration of follow-up was 10.7 ± 2.6 years. During the follow-up period, only 3 patients (0.7 %) were re-operated for left adnexal pathology, non-malignant in all cases. CONCLUSION: In women undergoing vaginal hysterectomy for pelvic organ prolapse without opportunistic adnexectomy, preservation of the adnexa poses only a very low risk for adnexal pathology or need for reoperation later in life.

Comparison of Readmission Rates for Same-Day Versus Next-Day Discharge After Benign Vaginal Hysterectomy.

IMPORTANCE: Same-day discharge (SDD) for laparoscopic hysterectomy is shown to be safe and acceptable, but data for vaginal hysterectomy (VH) are lacking. OBJECTIVE: The aim of this study was to compare 30-day readmission rates, timing, and reasons for readmission for SDD versus next-day discharge (NDD) after VH. STUDY DESIGN: This was a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2019. Cases of VH with or without prolapse repair were identified by Current Procedural Terminology codes. The primary outcome was 30-day readmissions after SDD versus NDD. Secondary outcomes included reasons for and time to readmission and a subanalysis evaluating 30-day readmissions for those with prolapse repair. Unadjusted and adjusted odds ratios were determined using univariate and multivariate analyses. RESULTS: There were 24,277 women included; 4,073 (16.8%) were SDD. The 30-day readmission rate was low (2.0%; 95% confidence interval [CI], 1.8-2.2%), with no difference in odds of readmission for SDD versus NDD after VH in multivariate analysis (SDD adjusted odds ratio [aOR], 0.9; 95% CI, 0.7-1.2). Results were similar in our subanalysis of VH with prolapse surgery (SDD aOR, 0.94; 95% CI, 0.55-1.62). Median time to readmission was 11 days and did not differ (SDD interquartile range, 5, 16 [range, 0-29] vs NDD, 7, 16 [range, 1-30]; Z = -1.30; P = 0.193). The most common reasons for readmission were bleeding (15.9%), infection (11.6%), bowel obstruction (8.7%), pain (6.8%), and nausea/emesis (6.8%). CONCLUSIONS: Same-day discharge after VH did not have an increased odds of 30-day readmission compared with NDD. This study, with preexisting data, supports the practice of SDD after benign VH in low-risk patients.

Vaginal Cuff Dehiscence in Transgender Patients After Minimally Invasive Hysterectomy.

STUDY OBJECTIVE: To compare rates of vaginal cuff dehiscence (VCD) in transgender patients with cisgender patients after minimally invasive hysterectomy (MIH). DESIGN: We performed a single-surgeon, retrospective cohort analysis comparing the rates of VCD in patients undergoing MIH for gender affirmation with other indications (benign, malignant, prophylactic) with our study surgeon between January, 2015, and December, 2021. SETTING: Major, urban, academic tertiary care hospital in the United States. PATIENTS: 166 patients met inclusion criteria with 49 of those patients undergoing MIH (29.5%) for gender affirmation. Of the remaining 117 patients, 92 (78.6%) underwent MIH for cancer, 15 (12.8%) for prophylaxis, and 10 (8.5%) for benign indications. INTERVENTIONS: Not applicable. MEASUREMENTS: We assessed included patients for baseline demographics, presence of risk factors for VCD, details of index hysterectomy, and details of cuff dehiscence events. MAIN RESULTS: Transgender patients tended to be younger at the time of surgery, but demographics were otherwise similar between both groups. Most transgender patients (n = 36, 73.5%) had both ovaries removed at the time of hysterectomy, 100% were on testosterone therapy pre- and postoperatively, and none used supplementary estrogen. Three of the 49 transgender patients (6.1%) experienced postoperative dehiscence of the vaginal cuff compared with 2 of the 117 cisgender patients (1.7%). This failed to reach statistical significance; however, our descriptive analysis showed that all cases of dehiscence in the cisgender group had identifiable precipitating factors (i.e., trauma). By comparison, all cases of dehiscence in the transgender group were spontaneous with few identifiable risk factors. CONCLUSION: Transgender patients undergoing MIH may be at increased risk of VCD, although the rarity of this surgical complication precluded determination of statistical significance in our data set. We propose testosterone exposure as a possible risk factor for VCD, although we cannot exclude other factors, such as young age, as drivers of VCD in this population. Future studies of biospecimens are needed to evaluate for cellular differences in these patients.

The impact of a previous cesarean section on the risk of perioperative and postoperative complications during vaginal hysterectomy.

OBJECTIVE: To investigate whether a previous cesarean section increases the risk of perioperative and postoperative complications during vaginal hysterectomy. METHODS: A retrospective cohort study of women who had undergone a vaginal hysterectomy for benign indications between 2014 and 2019 was conducted, comparing patients with or without a previous cesarean section. Perioperative and postoperative complications during vaginal hysterectomy were assessed according to the Clavien-Dindo classification system within 30 days of surgery. Duration of surgery, estimated blood loss, and postoperative hospitalization days were also recorded. A two-sided P value of less than 0.05 was considered significant. RESULTS: A total of 185 women were included, 25 (13.5%) patients had undergone a previous cesarean section (study group) and 160 (86.5%) had no history of cesarean section (comparison group). We found no significant differences in demographic and clinical characteristics as well as postoperative complications and interventions, duration of surgery, estimated blood loss, and postoperative hospitalization days (P > 0.05). However, patients who underwent two or more cesarean sections had a significantly (P = 0.01) higher rate and grade of complications during vaginal hysterectomy, compared with women with only one previous cesarean section. All women who underwent two or more cesarean sections had mild complications during vaginal hysterectomy (40% grade I and 60% grade II, P = 0.01). CONCLUSION: Vaginal hysterectomy is a safe procedure with few severe complications, regardless of a previous cesarean section. More than one previous cesarean section may increase the risk of minor complications during a vaginal hysterectomy. Patients who underwent a previous cesarean section could be reassured that they do not face an increased risk of complications during a vaginal hysterectomy.

Perioperative Outcomes for Same- Versus Next-Day Discharge After Benign Vaginal Hysterectomy.

IMPORTANCE: While same-day discharge (SDD) after laparoscopic hysterectomy is well supported, studies for vaginal hysterectomy (VH) are lacking. OBJECTIVE: The aim of the study was to compare 30-day complications for SDD versus next-day discharge (NDD) after benign VH. STUDY DESIGN: This was a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2019. Vaginal hysterectomy with or without urogynecology procedures was identified by Current Procedural Terminology codes. The primary outcome was 30-day composite complications of SDD versus NDD after VH. Secondary outcomes compared reoperations rates, time to and reasons for reoperation, and complications between the groups. Composite complications included death, major infection or wound complication, thromboembolism, transfusion, cardiopulmonary complication, renal insufficiency/failure, stroke, or reoperation. Unadjusted and adjusted odds ratios were determined using univariate and multivariate analysis. RESULTS: Of 24,277 people included, 4,073 (16.8%) were SDD, which were more likely to be younger ( P < 0.001), less likely to have hypertension (23.4 vs 18.3%, P < 0.0001) or diabetes (4.5 vs 3.3%, P = 0.001), and had shorter surgical procedures (100.7 ± 47.5 vs 111.2 ±57.5 minutes, P < 0.0001). There was no difference in composite complications after SDD versus NDD and this remained true in multivariate analysis (2.0 vs 2.3%, P = 0.30, SDD; adjusted odds ratio, 0.9; 95% confidence interval, 0.7-1.1). There was no difference in reoperation rates (0.9 vs 0.9%, P = 0.94) or reasons for reoperation. Time to first complication was shorter for SDD versus NDD (11 vs 13 days, P = 0.47). CONCLUSION: In our cohort of low-risk patients, SDD after VH with or without urogynecology procedures did not have an increased odds of 30-day composite complications.

Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.

OBJECTIVE: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair. METHODS: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S. sites. Participants underwent vaginal hysterectomy (if uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The intervention was perioperative (5 weeks or more preoperatively and 12 months postoperatively) vaginal estrogen compared with placebo cream. The primary outcome was time to failure by 12 months after surgery, defined by objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, symptomatic vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure compared with success, and multiple factors were compared, including age, time since menopause, race and ethnicity, parity, body mass index (BMI), baseline genital hiatus measurement, prolapse stage and point of maximal prolapse, surgery type (uterosacral or sacrospinous ligament suspension), and concomitant procedures. Factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusted for site and treatment group. Factors with P <.50 from this analysis were considered for inclusion in the final multivariable model; site and treatment group were kept in this model. RESULTS: One hundred eighty-six participants underwent surgery; 183 provided complete data. There were 30 failures (16.4%) and 153 successes (83.4%) at 12 months. On bivariate analysis, failure was associated with decreasing age, shorter duration since menopause, Latina ethnicity, and greater baseline genital hiatus. In the final multivariable model, which included age, BMI, and point of maximal prolapse, only age remained significantly associated with surgical failure (adjusted hazard ratio [per year] 0.92, 95% CI, 0.86-0.98, P =.016). CONCLUSION: Among postmenopausal women, younger age was associated with increased frequency of prolapse recurrence by 12 months after native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02431897.

Comparison of perioperative surgical outcomes between contained and free manual vaginal morcellation of large uteruses following total laparoscopic hysterectomy.

OBJECTIVE: To compare contained and free manual vaginal morcellation of large uteruses after total laparoscopic hysterectomy (TLH) in women at low risk of uterine malignancy in terms of feasibility and safety. METHODS: A single-center, observational, retrospective, cohort study was carried out including all patients undergoing TLH requiring manual vaginal morcellation for specimen extraction of large uteruses from January 2015 to August 2021 at the Division of Gynecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Bologna, Italy. Patients were divided into two groups according to the type of manual vaginal morcellation (contained or free), and compared in terms of demographic, clinical, and perioperative data. RESULTS: In all, 271 patients were included: 186 (68.6%) in the contained morcellation group and 85 (31.4%) in the free morcellation group. The mean operative time was significantly lower in the contained morcellation group compared with the free morcellation group (median [interquartile range] 130 [45] vs. 155 [60] min; P < 0.001). No significant difference was found in complications related to the morcellation step, overall, intraoperative and postoperative complications, estimated blood loss, length of hospital stays, uterine weight, and rate of occult malignancy between the two groups. CONCLUSION: Contained vaginal manual morcellation of the uterus after total laparoscopic hysterectomy using a specimen retrieval bag appears to be a safe procedure with significantly lower operative time than free vaginal manual morcellation.

Maintaining the apex: a novel technique for vault suspension during vaginal hysterectomy.

INTRODUCTION AND HYPOTHESIS: Post-hysterectomy vault prolapse poses significant challenges to patients and surgeons alike. Despite numerous surgical interventions during initial vaginal hysterectomy to counteract this, a comparative analysis of their efficacy is limited. This study introduces a pioneering technique intended to avert vault prolapse during vaginal hysterectomy by harmoniously merging level 1 and level 2 support. METHODS: After obtaining informed consent, we recorded a variation of the McCall technique performed during vaginal hysterectomy and anterior repair. Patient follow-ups were conducted up to 6 months post-operation to evaluate anatomical outcomes and quality of life. RESULTS: A total of 46 women underwent the surgery. Anatomical evaluations at the 6-month mark were commendable, with no recurrence instances. Quality-of-life assessments, using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), showcased substantial improvement. CONCLUSION: Our novel approach to vault suspension provides an uncomplicated, easily impartible, surgical procedure utilizing standard sutures. We believe that this approach is both enduring and safe.

Feasibility and safety of a surgical training program in total laparoscopic hysterectomy: Results of a pilot trial.

BACKGROUND: It is widely accepted total laparoscopic hysterectomy (TLH) and vaginal hysterectomy are less invasive procedures compared to total abdominal hysterectomy (TAH). However, rates of TAH remain unreasonably high. AIM: To pilot-test a model of training for practising obstetricians and gynaecologists (O&Gs) in TLH. MATERIALS AND METHODS: Training of participating O&Gs was conducted across four hospitals in Queensland, Australia, while other O&Gs were observed as contemporary controls. Type of hysterectomy, details of the surgery, including adverse events, were collected from hospital medical records. RESULTS: Eleven O&Gs completed the pre-intervention and intervention training periods, and nine completed the post-intervention follow-up. TLH rates increased from 24% prior to 75% during and 68% after intervention. Overall, the uptake rate of TLH showed a two-fold increase during the intervention period (2.08, 95% CI: 1.16-8.56, P < 0.001) and a 12% increase was retained during the follow-up period (1.12, 95% CI: 0.54-4.02, P = 0.427). Pre-intervention, across all sites, 24% of hysterectomies were performed via TAH by the participating specialist trainees, which decreased to 13% during the intervention and 14% during follow-up. The rate of adverse events decreased from 13.5% at pre-intervention, to 6.4% during and 4.2% post-intervention. By comparison, no change in surgical approach or rate of adverse events was observed in the control group. CONCLUSIONS: The implementation of a formal and structured surgical training program teaching TLH resulted in important benefits to trainees, patients and society in the four trial hospitals.