Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

• ClinicalTrials.gov Identifier: NCT01594372
• Recruitment Status: Terminated
• First Posted: May 9, 2012
• Last Update Posted: May 8, 2015
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Vatche Arakel Minassian, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Uterine Prolapse	Procedure: Laparoscopic supracervical hysterectomy with sacropexy; Procedure: Vaginal hysterectomy with uterosacral colposuspension	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Laparoscopic Repair; Laparoscopic supracervical hysterectomy with sacropexy	Procedure: Laparoscopic supracervical hysterectomy with sacropexy; 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
Active Comparator: Vaginal Repair; Vaginal hysterectomy with uterosacral colposuspension	Procedure: Vaginal hysterectomy with uterosacral colposuspension; 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.

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 24 months ]
2. Absence of re-treatment for prolapse at 2 years [ Time Frame: 24 months ]
3. A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" [ Time Frame: 24 months ]
   This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).

Secondary Outcome Measures :

1. Changes in POPQ measurements [ Time Frame: baseline, 6 week, and 3, 12, and 24 months ]
2. Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment [ Time Frame: baseline, 3, 12, and 24 months ]
   EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire
3. Change in patient reported sexual questionnaire, PISQ [ Time Frame: baseline, 3, 12 and 24 months ]
   PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire
4. Frequencies of surgical and post-operative complications [ Time Frame: up to 2 years post-operatively ]
   Complications will be classified and reported, based on severity.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Massachusetts

Brigham And Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

• Principal Investigator: Vatche A Minassian, MD, MPH; Brigham and Women's Hospital

More Information

• Responsible Party: Vatche Arakel Minassian, Director of Urogynecology, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01594372
• Other Study ID Numbers: VM-2012-01
• First Posted: May 9, 2012
• Last Update Posted: May 8, 2015
• Last Verified: May 2015

Keywords provided by Vatche Arakel Minassian, Brigham and Women's Hospital:

Uterine Prolapse; Laparoscopy; Hysterectomy, vaginal

Additional relevant MeSH terms:

Uterine Prolapse; Prolapse; Pathological Conditions, Anatomical; Uterine Diseases; Pelvic Organ Prolapse