Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
NCT ID: NCT02877407
Last Updated: 2016-08-25
Study Results
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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UNKNOWN
NA
146 participants
INTERVENTIONAL
2016-06-30
2017-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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laparoscopic/robotic-assisted hysteropexy
patient who undergo laparoscopic/robotic-assisted hysteropexy
patient who undergo laparoscopic/robotic-assisted hysteropexy
vaginal hysterectomy
patient who undergo vaginal hysterectomy
patient who undergo vaginal hysterectomy
Interventions
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patient who undergo laparoscopic/robotic-assisted hysteropexy
patient who undergo vaginal hysterectomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* significantly enlarged fibroid uterus
* postmenopausal uterine bleeding
* endometrial pathology
* on tamexifen
* concomitant medical problems precluding general anesthesia or surgery
* damaged agreement ability
60 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Dong Hoon Suh
associate professor
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
Countries
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Central Contacts
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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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