Hysterectomy Techniques for Uterine Prolapse
(ColoplastLSC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCecile Ferrando, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal hysterectomy versus laparoscopic supracervical hysterectomy. The secondary objectives are to determine if there are differences in intraoperative adverse events and postoperative mesh-related complications and prolapse recurrence between the groups.

Eligibility Criteria

This trial is for women aged 18 or older who need surgery (laparoscopic sacrocolpopexy) for uterovaginal prolapse and want a hysterectomy at the same time. They must have a recent normal PAP smear. Women can't join if they've had previous apical prolapse surgery, can't consent, need unrelated surgeries, wish to keep their uterus, don't understand English, or have health issues preventing laparoscopy.

Inclusion Criteria

Patient's must have an up-to-date PAP smear on record, or a PAP smear is performed in the office and verified to be normal pre-enrollment

I am over 18 and planning a surgery for pelvic organ prolapse with a hysterectomy.

I may have additional procedures for prolapse or incontinence during my surgery.

Exclusion Criteria

I have a health condition that prevents me from having laparoscopic surgery.

Inability to provide informed consent

I have had surgery for uterine prolapse before.

See 4 more

Treatment Details

Interventions

Laparoscopic supracervical hysterectomy (Procedure)
Vaginal hysterectomy (Procedure)

Trial OverviewThe study compares surgical times between two types of hysterectomy during minimally invasive sacrocolpopexy: vaginal hysterectomy versus laparoscopic supracervical hysterectomy. It also looks at differences in intraoperative complications and postoperative issues like mesh-related problems and recurrence of prolapse.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Vaginal hysterectomyExperimental Treatment1 Intervention

Surgical procedure to remove the uterus

Group II: Laparoscopic supracervical hysterectomyActive Control1 Intervention

Minimally invasive procedure to remove a woman's uterus