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

Primary Purpose

Uterovaginal Prolapse, Hysteropexy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
patient who undergo laparoscopic/robotic-assisted hysteropexy
patient who undergo vaginal hysterectomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterovaginal Prolapse

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National Univesity Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

laparoscopic/robotic-assisted hysteropexy

vaginal hysterectomy

Arm Description

patient who undergo laparoscopic/robotic-assisted hysteropexy

patient who undergo vaginal hysterectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2016
Last Updated
August 24, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02877407
Brief Title
Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
Acronym
PROLAPSE
Official Title
A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse prospective randomized clinical trial patient 60yrs or more women and 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 recurrence of uterovaginal prolapse POP-Q stage II-IV recurrence of associated symptom secondary endpoint postoperative 1 year QOL, degree of satisfaction evaluation operative time, estimated blood loss hospitalization period, postoperative pain, return to normal activity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterovaginal Prolapse, Hysteropexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic/robotic-assisted hysteropexy
Arm Type
Other
Arm Description
patient who undergo laparoscopic/robotic-assisted hysteropexy
Arm Title
vaginal hysterectomy
Arm Type
Other
Arm Description
patient who undergo vaginal hysterectomy
Intervention Type
Procedure
Intervention Name(s)
patient who undergo laparoscopic/robotic-assisted hysteropexy
Intervention Type
Procedure
Intervention Name(s)
patient who undergo vaginal hysterectomy
Primary Outcome Measure Information:
Title
recurrence rate (%)
Description
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
Time Frame
postoperative 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Hun Suh, associate professor
Email
sdhwcj@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Hun Suh, associate professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Univesity Bundang Hospital
City
Seongnam-si
State/Province
Kyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Hun Suh, associate professor

12. IPD Sharing Statement

Learn more about this trial

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

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