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Suture
Absorbable vs Permanent Sutures for Pelvic Organ Prolapse
N/A
Recruiting
Led By Laura Dhariwal, MD
Research Sponsored by Atlantic Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare absorbable and permanent sutures for treating pelvic organ prolapse to see which is more effective and has fewer suture-related complications.
Who is the study for?
This trial is for women over 18 who are patients at Atlantic Urogynecology Associates and will undergo sacrospinous ligament suspension at specific medical centers. It's not for those with pelvic radiation history, past prolapse repairs, or current gynecologic cancers.
What is being tested?
The study compares two types of stitches used in pelvic organ prolapse surgery: absorbable sutures that dissolve over time versus permanent ones that stay in the body. Participants are randomly assigned to one of the two options and followed up for a year.
What are the potential side effects?
Potential side effects may include complications related to the type of suture used, such as discomfort or the need for suture removal if permanent stitches are involved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
Secondary study objectives
PGI-I
Prolapse Recurrence
Suture-related Complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Permanent SutureExperimental Treatment1 Intervention
Permanent suture for sacrospinous ligament suspension
Group II: Absorbable SutureExperimental Treatment1 Intervention
Absorbable suture for sacrospinous ligament suspension
Find a Location
Who is running the clinical trial?
Atlantic Health SystemLead Sponsor
54 Previous Clinical Trials
7,487 Total Patients Enrolled
Laura Dhariwal, MDPrincipal InvestigatorAtlantic Health System
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had radiation treatment in the pelvic area in the past.You did not have a specific surgery called sacrospinous ligament suspension, as decided by the surgeon during the operation.You currently have cancers in your reproductive system.You have had surgery to repair a prolapse in the past.This criterion specifies that only patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers are eligible for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Permanent Suture
- Group 2: Absorbable Suture
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.
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