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RecruitingACTRN12622000830796

Comparing Vaginal Hysterectomy and Manchester Procedure for uterine prolapse

A prospective cohort study for success of vaginal hysterectomy with vault suspension compared to Manchester-Fothergill Procedure for utero-vaginal prolapse

Sponsor

Mercy Hospital

Enrollment

202 participants

Start Date

Jul 5, 2022

Study Type

Interventional

Conditions

pelvic organ prolapseuterovaginal prolapse

Summary

The Manchester Procedure (MP) and vaginal hysterectomy with vault suspension (VH) are two surgical options for the treatment of pelvic organ prolapse (POP). The evidence of benefit is currently limited to one prospective trial and several retrospective reviews. The two procedures have been studied in isolation though much more data exists for VH. Recent Danish registry data in a matched cohort study (n=590) suggested prolapse outcomes after Manchester repair were better than those after vaginal hysterectomy with vault suspension. In addition to the question of effectiveness of the procedure, the economic benefits of MP versus VH have been studied in the international literature. Costs for the first 20 months after the operation were higher in the VH group when analyzing the primary operation only, and higher still when including subsequent activities within 20 months. Given the MP is performed far less frequently in Australia, presumably due to patient selection and surgeon preference, there is a benefit for the local and international community to learn more about the differences in outcome between the procedures. Local data that shows equivalent outcomes may encourage increased uptake of the procedure which may lead to health gains for the patient and improved economic outcomes for hospitals.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Pelvic organ prolapse (POP) is a common condition in women where the pelvic organs — such as the uterus, bladder, or bowel — descend into or out of the vagina due to weakened support tissues. Two surgical options for treating uterine prolapse are vaginal hysterectomy with vault suspension (removing the uterus and supporting the top of the vagina) and the Manchester Procedure (shortening the ligaments supporting the uterus and repairing the vaginal wall, while keeping the uterus). Both operations are effective, but the Manchester Procedure is performed far less often in Australia despite some evidence suggesting it may produce better prolapse outcomes with lower costs. This randomised controlled trial directly compares the two procedures in women aged 18–80 with symptomatic stage I–III prolapse who are choosing surgical treatment. Outcomes including prolapse recurrence, quality of life, sexual function, and recovery are tracked at 12 months. To be eligible, you must not have had previous prolapse surgery, must not have had pelvic surgery within the last year, and must not have significant uterine pathology that would make keeping the uterus unsafe. The study is run through Mercy Hospital.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

As is usual practice, participants electing to undergo pelvic organ prolapse surgery would be offered uterine preserving surgery such as Manchester procedure (MP) as well as hysterectomy. This is done

As is usual practice, participants electing to undergo pelvic organ prolapse surgery would be offered uterine preserving surgery such as Manchester procedure (MP) as well as hysterectomy. This is done at a face to face consult with a Urogynaecologist or trainee under the supervision of a Urogynaecologist. After being provided with verbal and written information, patients will choose which procedure they will undergo to address their prolapse. All patients who choose either a MP will be offered enrolment in the study. The Manchester repair will be performed by a Urogynaecologist and/or Urogynaecology subspecialty trainee. The whole procedure would take about 1.5hrs including a cystoscopy at completion.

Locations(3)

Mercy Hospital for Women - Heidelberg

VIC, Australia

Monash Medical Centre - Moorabbin campus - East Bentleigh

VIC, Australia

Cabrini Hospital - Malvern - Malvern

VIC, Australia

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ACTRN12622000830796

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