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

Seoul National University Hospital146 enrolled

Overview

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Uterovaginal Prolapse Hysteropexy

Interventions

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Univesity Bundang Hospital

Seongnam-si, Kyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

recurrence rate (%)

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

Time frame: postoperative 1 year

Central Contacts

Dong Hun Suh, associate professor

CONTACT

sdhwcj@naver.com

Data from ClinicalTrials.gov

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