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Procedure

Sacrocolpopexy + Posterior Repair for Prolapse-Related Bowel Symptoms

N/A

Waitlist Available

Led By Edgar L LeClaire, MD, MS

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Posterior vaginal bulge ≤2cm beyond the hymen

Female Gender

Must not have

History of colorectal surgery

Age < 21

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months postoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial found that patients who had both laparoscopic sacrocolpopexy and posterior repair had better bowel symptom scores at 3 months post-op than those who only had laparoscopic sacrocolpopexy.

Who is the study for?

This trial is for women who can fill out English questionnaires and attend study visits for 6 months. They should have a posterior vaginal bulge ≤2cm beyond the hymen with bowel symptoms (PFDI-O score ≥3). It's not for those under 21, pregnant, with past colorectal surgery or pelvic radiation, inflammatory bowel disease, or previous sacrocolpopexy.

What is being tested?

The study is testing if adding a posterior repair to laparoscopic sacrocolpopexy improves bowel symptoms in women with uterine or vaginal prolapse better than just the sacrocolpopexy alone after three months.

What are the potential side effects?

Possible side effects may include discomfort at the surgical site, infection risk from surgery, bleeding complications, and potential issues related to general anesthesia used during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vaginal bulge extends 2cm or less beyond the hymen.

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I am female.

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I experience significant bowel symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for colorectal issues.

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I am younger than 21 years old.

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I have been diagnosed with inflammatory bowel disease.

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I have had radiation therapy to my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(obstructed defecation symptoms)

Secondary study objectives

(correlation between bowel symptoms scores and 3D ultrasound measurements)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: LSCP OnlyActive Control1 Intervention

A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, is used utilizing robot-assisted Laparoscopic Sacrocolopopexy.

Group II: LSCP + PRActive Control2 Interventions

The Laparoscopic Sacrocolopopexy involves a Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, utilizing robot-assisted Laparoscopic Sacrocolopopexy. In addition, patients will receive posterior repair. Posterior repair is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with posterior repair. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure.

0 / 7Eligibility criteria met