Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Uterine Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01594372
• Other study ID #: VM-2012-01
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Brigham And Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Absence of re-treatment for prolapse at 2 years		24 months
Primary	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	Changes in POPQ measurements		baseline, 6 week, and 3, 12, and 24 months
Secondary	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	baseline, 3, 12, and 24 months
Secondary	Change in patient reported sexual questionnaire, PISQ	PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire	baseline, 3, 12 and 24 months
Secondary	Frequencies of surgical and post-operative complications	Complications will be classified and reported, based on severity.	up to 2 years post-operatively