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

NCT02877407 · Seoul National University Hospital · Updated 25 Aug 2016

What is being tested: patient who undergo laparoscopic/robotic-assisted hysteropexy; patient who undergo vaginal hysterectomy
For: Uterovaginal Prolapse; Hysteropexy
Kind of study: Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join: Ages 60 years and older. About 146 people. The full rules are on the registry page.
Where: South Korea
When: Starts or started June 2016, ends June 2017. Registered 24 Aug 2016.
Results: None posted yet.

In the researchers' words

* 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

ClinicalTrials.gov, NCT02877407

Sites

Seoul National Univesity Bundang HospitalSeongnam-si, Kyeonggi-do, South Korea