Pelvic Organ ProlapseNCT00937430
Bowel Preparation and Pelvic Organ Prolapse Surgery
A study testing Bowel preparation (Fleets enema) in people with Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Bowel preparation (Fleets enema)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Bowel preparation (Fleets enema)
- Keywords
- Pelvic organ prolapse, Bowel preparation
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel preparation (Fleets enema)Other
Use of Bowel preparation (Fleets enema)
| Study group | Role | What they receive |
|---|---|---|
| Bowel preparation group | Experimental | Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery. Receives: Other: Bowel preparation (Fleets enema) |
| No Bowel preparation group | No intervention | Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the return of bowel function after pelvic organ prolapse surgery.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel N Pauls, M.D., Study director, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937430
- Sponsor's protocol ID
- 09001
- Status last verified
- Feb 2014
- First submitted
- 9 Jul 2009
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
- ClinicalTrials.gov ID
- NCT00937430
- Acronym / sponsor ID
- 09001
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Bowel preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowel preparation group | Experimental | Other: Bowel preparation (Fleets enema)Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery. |
| No Bowel preparation group | No intervention | –Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel preparation (Fleets enema)Use of Bowel preparation (Fleets enema) | Other | Bowel preparation group |
Primary outcome
Measure the return of bowel function after pelvic organ prolapse surgery.
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel N Pauls, M.D. study director
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel preparation (Fleets enema) in people with Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the return of bowel function after pelvic organ prolapse surgery. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.