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

Uterovaginal Prolapse Clinical Trial

— PROLAPSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877407
• Other study ID #: B-1605/345-002
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 24, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: Dong Hun Suh, associate professor
• Email: sdhwcj[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hysteropexy
• Prolapse
• Uterovaginal Prolapse

Intervention

Procedure:
• patient who undergo laparoscopic/robotic-assisted hysteropexy

• patient who undergo vaginal hysterectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univesity Bundang Hospital	Seongnam-si	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate (%)	recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year	postoperative 1 year	No