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

NCT ID: NCT02877407

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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* 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

Detailed Description

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Conditions

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Uterovaginal Prolapse Hysteropexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic/robotic-assisted hysteropexy

patient who undergo laparoscopic/robotic-assisted hysteropexy

Group Type OTHER

patient who undergo laparoscopic/robotic-assisted hysteropexy

Intervention Type PROCEDURE

vaginal hysterectomy

patient who undergo vaginal hysterectomy

Group Type OTHER

patient who undergo vaginal hysterectomy

Intervention Type PROCEDURE

Interventions

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patient who undergo laparoscopic/robotic-assisted hysteropexy

Intervention Type PROCEDURE

patient who undergo vaginal hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Hoon Suh

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Hun Suh, associate professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National Univesity Bundang Hospital

Seongnam-si, Kyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Hun Suh, associate professor

Role: CONTACT

Facility Contacts

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Dong Hun Suh, associate professor

Role: primary

Other Identifiers

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B-1605/345-002

Identifier Type: -

Identifier Source: org_study_id

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