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NCT00988975 Clinical Trial

Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

Rectocele Clinical Trial

Official title:
Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00988975
Other study ID # 09-046
Secondary ID
Status Recruiting
Phase N/A
First received September 30, 2009
Last updated October 1, 2009
Start date September 2009
Est. completion date December 2012

Study information
Verified date October 2009
Source Urogynecology Associates, Indiana
Contact Douglass S Hale, MD
Phone 317-962-6600
Email dhale@clarian.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion Criteria:

- concomitant colo-rectal procedure

- allergy to pork

- any contraindication to laparoscopic sacrocolpopexy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Insertion of pelvicol graft
Pelvicol graft

Locations
Country Name City State
United States Clarian North Carmel Indiana
United States Clarian Methodist Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Urogynecology Associates, Indiana

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anatomic success of rectocele repair 6 months No
Secondary change in patient symptomatology post-operatively 6 months No
See also
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Recruiting NCT04009694 - Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse? N/A
Completed NCT02280382 - An Intervention to Improve Prolapse Using Femmeze® (v1) N/A
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Active, not recruiting NCT03714607 - Laser Therapy in Managing Vaginal Prolapse N/A
Active, not recruiting NCT06330857 - Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy N/A
Active, not recruiting NCT01097200 - Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse N/A
Recruiting NCT00162604 - Prophylactic Antibiotic Treatment During Vaginal Repair N/A
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Not yet recruiting NCT06252714 - Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele N/A
Completed NCT05894226 - Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele N/A
Completed NCT02971332 - Long Term Results of STARR With Contour Transtar N/A
Completed NCT04502953 - Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele N/A
Completed NCT04175782 - Enhanced Recovery Protocol in Urogynecologic Surgery N/A
Terminated NCT03944720 - Efficacy of Transvaginal Repair for Rectocele
Recruiting NCT04547816 - Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse Phase 3
Active, not recruiting NCT02231099 - Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery N/A
Completed NCT02659176 - Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele N/A