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

NCT02877407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2016-08-25

No results posted yet for this study

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

PROCEDURE

patient who undergo laparoscopic/robotic-assisted hysteropexy

PROCEDURE

patient who undergo vaginal hysterectomy

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Dong Hun Suh, associate professor · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02877407 on ClinicalTrials.gov