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

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)

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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