POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction

NCT ID: NCT03187054

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2022-09-30

Brief Summary

The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based surgery with simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.

Detailed Description

The PREPARE trial is a prospective, randomized trial conducted with the aim to determine non-inferiority of the primary outcome between POPQ-based surgery and simulated apical support-based surgery for anterior or posterior vaginal wall prolapse. Participants will undergo transvaginal surgery for prolapse, including the assigned procedure for anterior or posterior vaginal prolapse under general or spinal anesthesia. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive transvaginal vault suspension, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension with both delayed absorbable and permanent sutures, according to the preference of surgeon. Incontinence surgery will also be performed for women with documented urodynamic stress incontinence.

A standardized protocol for enrollment, treatment and data collection will be employed by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, it is our intent that when feasible and ethical, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks and 6, 12, and 24 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

POPQ-based surgery

will undergo anterior or posterior colporrhaphy for all of anterior or posterior vaginal prolapse stage 2 or greater (i.e. point Ba or Bp ≥-1 on the POPQ examination)

Group Type: ACTIVE_COMPARATOR

anterior or posterior colporrhaphy

Intervention Type: PROCEDURE

will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.

Simulated apical support-based surgery

will undergo anterior or posterior colporrhaphy only for the prolapse unresolved under simulated apical support (i.e. point Ba or Bp ≥-1 under simulated apical support)

Group Type: EXPERIMENTAL

anterior or posterior colporrhaphy

Intervention Type: PROCEDURE

will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.

Interventions

anterior or posterior colporrhaphy

will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• POPQ stage 2-4 prolapse
• Descent of vaginal apex or cervix at least ½ way into vaginal canal (i.e. POPQ point C ≥ -TVL/2)
• Correction of either anterior or posterior vaginal wall prolapse under simulated apical support (i.e. from stage 2 or greater to stage 0 or 1)
• Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
• Vaginal reconstructive surgery is planned, including a vaginal apical suspension procedure

Exclusion Criteria

• Large pelvic mass
• Previous prolapse surgery
• Known malignancy
• Two or more inpatient hospitalizations for medical comorbidities in the previous year
• Subject wishes to retain her uterus
• Subject is unable and unwilling to participate in

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Myung Jae Jeon

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myung Jae Jeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Myung Jae, Jeon

Seoul, , South Korea

Countries

South Korea

References

Jeon MJ, Kim CH, Cho HH, Suh DH, Kim SR. Preoperative POPQ versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE trial): study protocol for a randomised controlled trial. BMJ Open. 2020 Jan 6;10(1):e034170. doi: 10.1136/bmjopen-2019-034170.

Reference Type: DERIVED

PMID: 31911524 (View on PubMed)

Other Identifiers

SNUH-1705-062-853

Identifier Type: -

Identifier Source: org_study_id