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

August 24, 2016 updated by: Dong Hoon Suh, Seoul National University Hospital

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

  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyeonggi-do
      • Seongnam-si, Kyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National Univesity Bundang Hospital
        • Contact:
          • Dong Hun Suh, associate professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: laparoscopic/robotic-assisted hysteropexy
patient who undergo laparoscopic/robotic-assisted hysteropexy
Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexy
OTHER: vaginal hysterectomy
patient who undergo vaginal hysterectomy
Procedure: patient who undergo vaginal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate (%)
Time Frame: postoperative 1 year
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
postoperative 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Dong Hun Suh, associate professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (ESTIMATE)

August 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1605/345-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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