Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
PROLAPSE
A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
1 other identifier
interventional
146
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 25, 2016
August 1, 2016
1 year
August 16, 2016
August 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence rate (%)
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
postoperative 1 year
Study Arms (2)
laparoscopic/robotic-assisted hysteropexy
OTHERpatient who undergo laparoscopic/robotic-assisted hysteropexy
vaginal hysterectomy
OTHERpatient who undergo vaginal hysterectomy
Interventions
Eligibility Criteria
You may qualify if:
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National Univesity Bundang Hospital
Seongnam-si, Kyeonggi-do, 13620, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Hun Suh, associate professor
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 24, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 25, 2016
Record last verified: 2016-08