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

Not Applicable

• Conditions: Uterovaginal Prolapse; Hysteropexy
• Interventions: Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexy; Procedure: patient who undergo vaginal hysterectomy

• Registration Number: NCT02877407
• Lead Sponsor: Seoul National University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-24
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

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

Exclusion Criteria

• abnormal uterine bleeding
• significantly enlarged fibroid uterus
• postmenopausal uterine bleeding
• endometrial pathology
• on tamexifen
• concomitant medical problems precluding general anesthesia or surgery
• damaged agreement ability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic/robotic-assisted hysteropexy	patient who undergo laparoscopic/robotic-assisted hysteropexy	patient who undergo laparoscopic/robotic-assisted hysteropexy
vaginal hysterectomy	patient who undergo vaginal hysterectomy	patient who undergo vaginal hysterectomy

Primary Outcome Measures

Name	Time	Method
recurrence rate (%)	postoperative 1 year	recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year

Trial Locations

Locations (1)

Seoul National Univesity Bundang Hospital; 🇰🇷 Seongnam-si, Kyeonggi-do, Korea, Republic of