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

Seoul National University logo

Seoul National University

Status

Unknown

Conditions

Hysteropexy
Uterovaginal Prolapse

Treatments

Procedure: patient who undergo vaginal hysterectomy
Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexy

Study type

Interventional

Funder types

Other

Identifiers

NCT02877407
B-1605/345-002

Details and patient eligibility

About

  • 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

Enrollment

146 estimated patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

146 participants in 2 patient groups

laparoscopic/robotic-assisted hysteropexy
Other group
Description:
patient who undergo laparoscopic/robotic-assisted hysteropexy
Treatment:
Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexy
vaginal hysterectomy
Other group
Description:
patient who undergo vaginal hysterectomy
Treatment:
Procedure: patient who undergo vaginal hysterectomy

Trial contacts and locations

1

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Central trial contact

Dong Hun Suh, associate professor

Data sourced from clinicaltrials.gov

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