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Clinical Trials/NCT02877407
NCT02877407
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country146 target enrollmentJune 2016
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ConditionsUterovaginal ProlapseHysteropexy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterovaginal Prolapse
Sponsor
Seoul National University Hospital
Enrollment
146
Locations
1
Primary Endpoint
recurrence rate (%)
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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
Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong Hoon Suh

associate professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

recurrence rate (%)

Time Frame: postoperative 1 year

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

Study Sites (1)

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