Clinical trial NCT01594372: 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
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Prolapse
Keywords: Uterine Prolapse
Laparoscopy
Hysterectomy, vaginal
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: 24 months
measure: Absence of re-treatment for prolapse at 2 years
timeFrame: 24 months
measure: A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
timeFrame: 24 months
Secondary outcomes:
measure: Changes in POPQ measurements
timeFrame: baseline, 6 week, and 3, 12, and 24 months
measure: Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment
timeFrame: baseline, 3, 12, and 24 months
measure: Change in patient reported sexual questionnaire, PISQ
timeFrame: baseline, 3, 12 and 24 months
measure: Frequencies of surgical and post-operative complications
timeFrame: up to 2 years post-operatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Vatche A Minassian, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: