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

Primary Purpose

Rectocele

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insertion of pelvicol graft
Sponsored by
Urogynecology Associates, Indiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clarian NorthRecruiting
  • Clarian MethodistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pelvicol graft

No graft material

Arm Description

No graft material

Outcomes

Primary Outcome Measures

Anatomic success of rectocele repair

Secondary Outcome Measures

change in patient symptomatology post-operatively

Full Information

First Posted
September 30, 2009
Last Updated
October 1, 2009
Sponsor
Urogynecology Associates, Indiana
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1. Study Identification

Unique Protocol Identification Number
NCT00988975
Brief Title
Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging
Official Title
Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Urogynecology Associates, Indiana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvicol graft
Arm Type
Active Comparator
Arm Title
No graft material
Arm Type
No Intervention
Arm Description
No graft material
Intervention Type
Procedure
Intervention Name(s)
Insertion of pelvicol graft
Intervention Description
Pelvicol graft
Primary Outcome Measure Information:
Title
Anatomic success of rectocele repair
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in patient symptomatology post-operatively
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglass S Hale, MD
Phone
317-962-6600
Email
dhale@clarian.org
Facility Information:
Facility Name
Clarian North
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglass S Hale, MD
Facility Name
Clarian Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglass S Hale, MD

12. IPD Sharing Statement

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

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