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Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Primary Purpose

Uterine Prolapse

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Laparoscopic supracervical hysterectomy with sacropexy

Vaginal hysterectomy with uterosacral colposuspension

About this trial

This is an interventional treatment trial for Uterine Prolapse focused on measuring Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Brigham And Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Laparoscopic Repair

Vaginal Repair

Arm Description

Laparoscopic supracervical hysterectomy with sacropexy

Vaginal hysterectomy with uterosacral colposuspension

Outcomes

Primary Outcome Measures

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)

Absence of re-treatment for prolapse at 2 years

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).

Secondary Outcome Measures

Changes in POPQ measurements

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

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

Change in patient reported sexual questionnaire, PISQ

PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

Frequencies of surgical and post-operative complications

Complications will be classified and reported, based on severity.

Full Information

NCT ID

NCT01594372

First Posted

May 4, 2012

Last Updated

March 2, 2022

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01594372

Brief Title

Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Official Title

Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Prolapse

Keywords

Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Repair

Arm Type

Active Comparator

Arm Description

Laparoscopic supracervical hysterectomy with sacropexy

Arm Title

Vaginal Repair

Arm Type

Active Comparator

Arm Description

Vaginal hysterectomy with uterosacral colposuspension

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic supracervical hysterectomy with sacropexy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Vaginal hysterectomy with uterosacral colposuspension

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

Absence of re-treatment for prolapse at 2 years

Time Frame

24 months

Title

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

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Changes in POPQ measurements

Time Frame

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

Title

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

Description

Time Frame

baseline, 3, 12, and 24 months

Title

Change in patient reported sexual questionnaire, PISQ

Description

PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

Time Frame

baseline, 3, 12 and 24 months

Title

Frequencies of surgical and post-operative complications

Description

Complications will be classified and reported, based on severity.

Time Frame

up to 2 years post-operatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vatche A Minassian, MD, MPH

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham And Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

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