Comparing Vaginal Hysterectomy and Manchester Procedure for uterine prolapse

Not Applicable

Recruiting

• Conditions: pelvic organ prolapse; uterovaginal prolapse; Surgery - Surgical techniques

• Registration Number: ACTRN12622000830796
• Lead Sponsor: Mercy Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-14
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 202

Inclusion Criteria

Inclusion Criteria
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 Criteria

Exclusion Criteria
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the recurrence of prolapse after MP versus vaginal hysterectomy (VH) at 6 months, 2 years, 5 years defined as no recurrent prolapse requiring repeat prolapse surgery or pessary assessed by absence of bulge sensation as reported by the patient.<br><br>[ 6 months (primary time point), 2 years, 5 years post surgery]