Dataset Information

Vaginal-assisted Laparoscopic Sacrohysteropexy and Vaginal Hysterectomy with Vaginal Vault Suspension for Advanced Uterine Prolapse: 12-month Preliminary Results of a Randomized Controlled Study.

ABSTRACT:

Objective

Vaginal-assisted laparoscopic sacrohysteropexy (VALH) is a new modified form of uterine-sparing prolapse surgery using a combined vaginal and laparoscopic approach. We aimed to compare 1 year efficacy and safety of VALH and vaginal hysterectomy with vaginal vault suspension (VH + VVS) in the surgical treatment of apical pelvic organ prolapse (POP).

Materials and methods

Women who requested surgical treatment for stage 2-4 symptomatic uterine prolapse were recommended to participate in one year-long randomized study between July 2017 and January 2019. POP Quantification (POP-Q) examination and validated questionnaires such as International Consultation on Incontinence Questionnaire Vaginal Symptoms (IVIQ-VS) survey, Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire Short Form (IIQ-7), and Patient Global Impression of Improvement (PGI-I) were recorded at baseline and 12 months after surgery. The main primary outcome measure was apical prolapse recurrence. Secondary results were duration of surgery, pain score, blood loss, postoperative hospital stay, and quality of life scores related to prolapse.

Results

There were 15 women in VALH and 19 women in the VH + VVS group. ICIQ-VS score, ICIQ-QOL, UDI-6, and IIQ-7 scores were improved for both groups. According to the PGI-I scores, 80% of subjects in the VALH group, and 100% in the VH + VVS group, were "very much better" or "much better" with their prolapse symptoms at their 1-year follow-up. There was no reoperation or operation-related complication in both groups.

Conclusion

VALH and VH + VVS have similar 1-year cure rates and patient satisfaction.

SUBMITTER: Cengiz H

PROVIDER: S-EPMC7968601 | biostudies-literature | 2021 Jan-Mar

REPOSITORIES: biostudies-literature

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Publications

Vaginal-assisted Laparoscopic Sacrohysteropexy and Vaginal Hysterectomy with Vaginal Vault Suspension for Advanced Uterine Prolapse: 12-month Preliminary Results of a Randomized Controlled Study.

Cengiz Huseyin H Yildiz Sukru S Alay Ismail I Kaya Cihan C Eren Ecem E Iliman Derya Ece DE

Gynecology and minimally invasive therapy 20210130 1

<h4>Objective</h4>Vaginal-assisted laparoscopic sacrohysteropexy (VALH) is a new modified form of uterine-sparing prolapse surgery using a combined vaginal and laparoscopic approach. We aimed to compare 1 year efficacy and safety of VALH and vaginal hysterectomy with vaginal vault suspension (VH + VVS) in the surgical treatment of apical pelvic organ prolapse (POP).<h4>Materials and methods</h4>Women who requested surgical treatment for stage 2-4 symptomatic uterine prolapse were recommended to ...[more]

PMID: 33747770

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Project description:Introduction and hypothesisThe treatment of post-hysterectomy vaginal vault prolapse (VVP) has been investigated in several randomized clinical trials (RCTs), but a systematic review of the topic is still lacking. The aim of this study is to compare the effectiveness of treatments for VVP.MethodsWe performed a systematic review and meta-analysis of the literature on the treatment of VVP found in PubMed and Embase. Reference lists of identified relevant articles were checked for additional articles. A network plot was constructed to illustrate the geometry of the network of the treatments included. Only RCTs reporting on the treatment of VVP were eligible, conditional on a minimum of 30 participants with VVP and a follow-up of at least 6 months.ResultsNine RCTs reporting 846 women (ranging from 95 to 168 women) met the inclusion criteria. All surgical techniques were associated with good subjective results, and without differences between the compared technique, with the exception of the comparison of vaginal mesh (VM) vs laparoscopic sacrocolpopexy (LSC). LSC is associated with a higher satisfaction rate. The anatomical results of the sacrocolpopexy (laparoscopic, robotic [RSC]. and abdominal [ASC]) are the best (62-91%), followed by the VM. However, the ranges of the anatomical outcome of VM were wide (43-97%). The poorest results are described for the sacrospinal fixation (SSF; 35-81%), which also correlates with the higher reoperation rate for pelvic organ prolapse (POP; 5-9%). The highest percentage of complications were reported after ASC (2-19%), VM (6-29%), and RSC (54%). Mesh exposure was seen most often after VM (8-21%). The rate of reoperations carried out because of complications, recurrence prolapse, and incontinence of VM was 13-22%. Overall, sacrocolpopexy reported the best results at follow-up, with an outlier of one trial reporting the highest reoperation rate for POP (11%). The results of the RSC are too small to make any conclusion, but LSC seems to be preferable to ASC.ConclusionsA comparison of techniques was difficult because of heterogeneity; therefore, a network meta-analysis was not possible. All techniques have proved to be effective. The reported differences between the techniques were negligible. Therefore, a standard treatment for VVP could not be given according to this review.

Project description:Introduction and hypothesisLaparoscopic mesh sacrohysteropexy offers a uterine-sparing alternative to vaginal hysterectomy with apical suspension, although randomised comparative data are lacking. This study was aimed at comparing the long-term efficacy of laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse.MethodsA randomised controlled trial comparing laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse was performed, with a minimum follow-up of 7 years. The primary outcome was reoperation for apical prolapse. Secondary outcomes included patient-reported mesh complications, Pelvic Organ Prolapse Quantification, Patient Global Impression of Improvement in prolapse symptoms and the International Consultation on Incontinence Questionnaire Vaginal Symptoms, Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and PISQ-12 questionnaires.ResultsA total of 101 women were randomised and 62 women attended for follow-up at a mean of 100 months postoperatively (range 84-119 months). None reported a mesh-associated complication. The risk of reoperation for apical prolapse was 17.2% following vaginal hysterectomy (VH) and 6.1% following laparoscopic mesh sacrohysteropexy (LSH; relative risk 0.34, 95% CI 0.07-1.68, p = 0.17). Laparoscopic sacrohysteropexy was associated with a statistically significantly higher apical suspension (POP-Q point C -5 vs -4.25, p = 0.02) and longer total vaginal length (9 cm vs 6 cm, p < 0.001). There was no difference in the change in ICIQ-VS scores between the two groups (ICIQ-VS change -22 vs -25, p = 0.59).ConclusionLaparoscopic sacrohysteropexy and vaginal hysterectomy with apical suspension have comparable reoperation rates and subjective outcomes. Potential advantages of laparoscopic sacrohysteropexy include a lower risk of apical reoperation, greater apical support and increased total vaginal length.

Project description:ImportanceVaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.ObjectiveTo compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.Design, setting, participantsAt 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.InterventionsNinety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.Main outcomes and measuresThe primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.ResultsA total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P?=?.06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P?=?<.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).Conclusions and relevanceAmong women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.Trial registrationClinicalTrials.gov Identifier: NCT01802281.

Project description:OBJECTIVE:To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN:Two parallel, multicentre, randomised trials. SETTING:28 UK centres and two South African centres. PARTICIPANTS:1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS:In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS:Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Dataset Information

Vaginal-assisted Laparoscopic Sacrohysteropexy and Vaginal Hysterectomy with Vaginal Vault Suspension for Advanced Uterine Prolapse: 12-month Preliminary Results of a Randomized Controlled Study.

Objective

Materials and methods

Results

Conclusion

Publications

Vaginal-assisted Laparoscopic Sacrohysteropexy and Vaginal Hysterectomy with Vaginal Vault Suspension for Advanced Uterine Prolapse: 12-month Preliminary Results of a Randomized Controlled Study.

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