Trial to Determine Which of Two Surgical Techniques Works... | NCT00988975

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

NCT00988975

Sponsor

Urogynecology Associates, Indiana

Status

Unknown status

Last Update Posted

Oct 2, 2009Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Rectocele

Interventions

Insertion of pelvicol graft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Sep 30, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelvicol graft	Active Comparator		Procedure: Insertion of pelvicol graft
No graft material	No Intervention	No graft material

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insertion of pelvicol graft	Procedure	Pelvicol graft	Pelvicol graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomic success of rectocele repair		6 months

Secondary Outcomes

Measure	Description	Time Frame
change in patient symptomatology post-operatively		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Douglass S Hale, MD	Contact	317-962-6600		dhale@clarian.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clarian North	Recruiting	Carmel	Indiana	46032	United States

Condition Browse Module

MeSH Terms

ID	Term
D020047	Rectocele

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided