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Procedure
Hysterectomy Techniques for Uterine Prolapse (Coloplast LSC Trial)
N/A
Recruiting
Led By Cecile Ferrando, M.D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18, who are to undergo laparoscopic sacrocolpopexy for uterovaginal prolapse and desire concurrent hysterectomy at the time of surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Coloplast LSC Trial Summary
This trial will compare two types of minimally invasive surgery for uterine prolapse, one with hysterectomy and one without. They will compare surgical time, intraoperative complications, postoperative mesh complications, and prolapse recurrence.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with surgical procedures such as infection, bleeding, pain at the incision site, anesthesia reactions, and specific complications related to each type of hysterectomy which will be monitored.
Coloplast LSC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and planning a surgery for pelvic organ prolapse with a hysterectomy.
Coloplast LSC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total surgical time - Time of incision to time of sacrocolpopexy completion
Secondary outcome measures
Post-operative mean difference ISI at 24 months
Post-operative mean difference PFDI-20 at 24 months
Post-operative mean difference PGII at 24 months
+4 moreColoplast LSC Trial Design
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
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,006 Total Patients Enrolled
Cecile Ferrando, M.D.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that prevents me from having laparoscopic surgery.I have had surgery for uterine prolapse before.I want to keep my uterus.I am over 18 and planning a surgery for pelvic organ prolapse with a hysterectomy.I need surgery not related to pelvic organ issues.I have had a surgery to support my pelvic organs.You are unable to understand or speak English well.I may have additional procedures for prolapse or incontinence during my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Vaginal hysterectomy
- Group 2: Laparoscopic supracervical hysterectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participants in this clinical research?
"As confirmed on clinicaltrials.gov, this experiment is still enrolling participants. It was created in March 2021 and further modified in July 2022."
Answered by AI
How many participants are taking part in this research study?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial remains active, having first gone public on March 16th 2021 and edited most recently on July 11th 2022. The initiative is currently recruiting 70 patients to participate at one site."
Answered by AI
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