NCT00988975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

3.3 years

First QC Date

September 30, 2009

Last Update Submit

October 1, 2009

Conditions

Rectocele

Outcome Measures

Primary Outcomes (1)

  • Anatomic success of rectocele repair

    6 months

Secondary Outcomes (1)

  • change in patient symptomatology post-operatively

    6 months

Study Arms (2)

Pelvicol graft

ACTIVE COMPARATOR
Procedure: Insertion of pelvicol graft

No graft material

NO INTERVENTION

No graft material

Interventions

Insertion of pelvicol graftPROCEDURE

Pelvicol graft

Pelvicol graft

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

You may not qualify if:

  • concomitant colo-rectal procedure
  • allergy to pork
  • any contraindication to laparoscopic sacrocolpopexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clarian North

Carmel, Indiana, 46032, United States

RECRUITING

Clarian Methodist

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Douglass S Hale, MD

CONTACT

317-962-6600dhale@clarian.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

US(2)