Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

NCT01594372 | Terminated

• 1 other identifier: VM-2012-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.

Conditions

Uterine Prolapse

Keywords

Uterine Prolapse; Laparoscopy; Hysterectomy, vaginal

Outcome Measures

Primary Outcomes (3)

• Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)

  24 months

• Absence of re-treatment for prolapse at 2 years

  24 months

• A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"

  This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).

  24 months

Secondary Outcomes (4)

• Changes in POPQ measurements

  baseline, 6 week, and 3, 12, and 24 months

• Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment

  baseline, 3, 12, and 24 months

• Change in patient reported sexual questionnaire, PISQ

  baseline, 3, 12 and 24 months

• Frequencies of surgical and post-operative complications

  up to 2 years post-operatively

Study Arms (2)

Laparoscopic Repair

ACTIVE COMPARATOR

Laparoscopic supracervical hysterectomy with sacropexy

Procedure: Laparoscopic supracervical hysterectomy with sacropexy

Vaginal Repair

ACTIVE COMPARATOR

Vaginal hysterectomy with uterosacral colposuspension

Procedure: Vaginal hysterectomy with uterosacral colposuspension

Interventions

Laparoscopic supracervical hysterectomy with sacropexy PROCEDURE

Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it

Laparoscopic Repair

Vaginal hysterectomy with uterosacral colposuspension PROCEDURE

Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.

Vaginal Repair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary symptomatic uterine prolapse
• ≥ 18 years of age
• Considering pelvic reconstructive surgery

You may not qualify if:

• Unwillingness to be randomized to one of two surgical approaches
• Pregnant or planning to maintain their future fertility
• Unable to have general anesthesia
• Currently undergoing chemotherapy OR has current or history of pelvic radiation
• Previous adverse reaction to synthetic mesh
• Recent history of abnormal paps (past 10 years)
• Cervical or uterine cancers
• Previous hysterectomy
• Previous central vault or uterine prolapse repair
• Uterus ≥ 14 weeks size
• Uterine cancer
• History of significant pelvic adhesive disease
• Elongated cervix (length D to C \> 6cm)
• Fibroid ≥ 7cm
• Post menopausal with enlarged uterus

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Uterine Prolapse

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Vatche A Minassian, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urogynecology

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

US (1)