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Procedure

Sacrocolpopexy + Posterior Repair for Prolapse-Related Bowel Symptoms

N/A

Waitlist Available

Led By Lieschen Quiroz, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months postoperative

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(obstructed defecation symptoms)

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,550 Total Patients Enrolled

Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma

4 Previous Clinical Trials

313 Total Patients Enrolled

Edgar L LeClaire, MD, MSPrincipal InvestigatorUniversity of Oklahoma

Media Library

Laparoscopic Sacrocolopopexy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03658395 — N/A

Vaginal Prolapse Research Study Groups: LSCP Only, LSCP + PR

Vaginal Prolapse Clinical Trial 2023: Laparoscopic Sacrocolopopexy Highlights & Side Effects. Trial Name: NCT03658395 — N/A

Laparoscopic Sacrocolopopexy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03658395 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively recruiting participants?

"This particular trial, which was first shared on July 19th 2018 and last modified on October 5th 2022 is not currently accepting candidates. However, there are 78 other trials actively recruiting patients at this time according to information available on clinicaltrials.gov."

Answered by AI

Is eligibility for this research limited to persons of a certain age range?

"As specified in the guidelines for this trial, eligible subjects must fall within a certain age range; 21 years of age at minimum and 80 years old at maximum."

Answered by AI

Am I eligible to join the clinical experiment?

"This research is seeking 60 people with a diagnosis of vaginal prolapse, aged between 21 and 80. The most important conditions for participation include: Female Gender, Ability to understand English language questionnaires, Capacity to attend follow-up visits over 6 months, A PFDI-O score of at least 3 points and Posterior vaginal bulge that does not exceed 2cm beyond the hymen."

Answered by AI

Recent research and studies

The American Journal of SurgeryJournal

Gynecologic Use of Robotically Assisted Laparoscopy: Sacrocolpopexy for the Treatment of High-grade Vaginal Vault Prolapse

Elliott, Daniel S., Igor Frank, David S. DiMarco, and George K. Chow. 2004. “Gynecologic Use of Robotically Assisted Laparoscopy: Sacrocolpopexy for the Treatment of High-grade Vaginal Vault Prolapse”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2004.08.022.

Clinical Obstetrics & GynecologyJournal

Laparoscopic Management of Incontinence and Pelvic Organ Prolapse

FRICK, ANNA C., and MARIE FIDELA R. PARAISO. 2009. “Laparoscopic Management of Incontinence and Pelvic Organ Prolapse”. Clinical Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/grf.0b013e3181b0bf69.

clinicaltrials.govStudy

Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

2018. "Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03658395.