Bowel Preparation and Pelvic Organ Prolapse Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by TriHealth Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
TriHealth Inc.
Information provided by:
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT00937430
First received: July 9, 2009
Last updated: July 10, 2009
Last verified: July 2009
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Purpose
The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Other: Bowel preparation (Fleets enema) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery. |
Resource links provided by NLM:
Further study details as provided by TriHealth Inc.:
Primary Outcome Measures:
- Measure the return of bowel function after pelvic organ prolapse surgery. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bowel preparation group
Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery.
|
Other: Bowel preparation (Fleets enema)
Use of Bowel preparation (Fleets enema)
|
|
No Intervention: No Bowel preparation group
Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery.
|
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are between the ages of 21-90 years.
- Have a posterior vaginal wall prolapse.
- Are undergoing vaginal prolapse reconstructive surgery including posterior repair with suspension of the vaginal apex (top) to the ligaments in your pelvis, repair of the cul de sac or "enterocele", with or without anti-incontinence surgery.
- Are receiving general anesthesia.
Exclusion Criteria:
- Patient undergoing concomitant anal sphincteroplasty, rectovaginal fistula repair, rectopexy, or rectal resection/reanastomosis.
- Patient undergoing any mesh augmentation.
- Patient with any neurological condition involving bowel function.
- Patient on regular narcotic medication preoperatively.
- Patient does not want to be in the group she was randomized to.
- Patient currently pregnant or planning to become pregnant, or breastfeeding.
- Patient with ascites.
- Patient with known or suspected gastrointestinal obstruction or perforation.
- Patient with history of hyperparathyroidism.
- Patient with dehydration.
- Patient with active inflammatory bowel disease.
- Patients with congestive heart failure.
- Patients with dialysis dependent renal disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937430
Contacts
| Contact: Apurva B Pancholy, M.D. | 513-862-4171 | apurva_pancholy@trihealth.com |
| Contact: Angie Fellner, Ph.D | 513-862-2330 | Angie_Fellner@trihealth.com |
Locations
| United States, Ohio | |
| Good Samaritan Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Apurva B Pancholy, M.D. 513-862-4171 apurva_pancholy@trihealth.com | |
| Contact: Angie Fellner, Ph.D 513-862-2330 Angie_Fellner@trihealth.com | |
| Sub-Investigator: Rachel N Pauls, M.D. | |
Sponsors and Collaborators
TriHealth Inc.
Investigators
| Study Director: | Rachel N Pauls, M.D. | TriHealth Inc. |
More Information
No publications provided
| Responsible Party: | Apurva B. Pancholy, M.D., TriHealth ( Good Samaritan Hospital, Bethesda North Hospital) |
| ClinicalTrials.gov Identifier: | NCT00937430 History of Changes |
| Other Study ID Numbers: | 09001 |
| Study First Received: | July 9, 2009 |
| Last Updated: | July 10, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by TriHealth Inc.:
|
Pelvic organ prolapse Bowel preparation |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical Sodium phosphate |
Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013