Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse — PROLAPSE  

Uterovaginal Prolapse Clinical Trial

Official title: A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse

Status Recruiting

Clinical Trial Summary

• objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse

• prospective randomized clinical trial

• patient

1. 60yrs or more women and

2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom

• number of patient: 146

• randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy

• follow up: postoperative 1 year

• primary endpoint: recurrence rate

1. recurrence of uterovaginal prolapse POP-Q stage II-IV

2. recurrence of associated symptom

• secondary endpoint

1. postoperative 1 year QOL, degree of satisfaction evaluation

2. operative time, estimated blood loss

3. hospitalization period, postoperative pain, return to normal activity

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysteropexy
• Prolapse
• Uterovaginal Prolapse

• NCT number: NCT02877407
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Dong Hun Suh, associate professor
• Email: sdhwcj@naver.com
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Completion date: June 2017