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
Mercy Hospital
202 participants
Jul 5, 2022
Interventional
Conditions
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
Inclusion Criteria1
- All participants between the ages of 18-80 with symptomatic stage I-III pelvic organ prolapse (POP) requesting surgery including hysterectomy, capable of providing informed consent and able to return for follow up.
Exclusion Criteria9
- Any previous prolapse surgery
- Previous surgery in the treatment area in the last year.
- Systemic steroids use within the last 3 months
- Pelvic organ prolapse (POP) > stage 3 according to pelvic organ prolapse quantification system
- Past history of prolapse surgery with transvaginal mesh
- Serious systemic disease or any chronic condition that could interfere with study compliance
- Uterine pathology that would make uterine preservation inappropriate
- Co-morbidities or surgical history that would make a particular approach inappropriate
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
Interested in this trial?
Get notified about updates and connect with the research team.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000830796