NCT02877407

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Uterovaginal Prolapse
• Hysteropexy

Interventions

Type	Name	Description
PROCEDURE	patient who undergo laparoscopic/robotic-assisted hysteropexy
PROCEDURE	patient who undergo vaginal hysterectomy

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-08-24
• Last updated: 2016-08-25

Locations

1 site across 1 country: South Korea