Colon CleansingNCT00981539
Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?
A study testing enema in people with Colon Cleansing, run by Illinois Urogynecology, Ltd. at 2 sites in United States.
Trial summary
Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colon Cleansing
- What is being tested?
- enema
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Sep 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female, AND
- undergoing vaginal surgery for prolapse.
Who cannot join
- pregnant women,
- age younger than eighteen,
- male sex, OR
- concurrent abdominal surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Illinois Urogynecology, LTD.
Oak Lawn, Illinois, 60453
Elser, 708-499-9800, delser@iultd.org
dfurlong@iultd.org
- Recruiting
Illinois Urogynecology, LTD.
Park Ridge, Illinois, 60068
Michael M Moen, MD, 847-825-1590
Sara Kostant, MD, 847-825-1590
About this study
Official title: Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?
Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.
Read the detailed description
The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.
- Conditions
- Colon Cleansing
- Being tested
- enema
- Keywords
- The focus of this study is to determine whether it is beneficial to administer enemas before surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enemaProcedure or surgery
Also called adult over the counter enema
pre operative rectal enema
one adult bottle to be used rectally the night before surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment : receives pre operative enema | Active comparator | one arm will receive pre operative enema Receives: Procedure: enema |
| no enema | No intervention | this group will not receive pre operative enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection rate
Measured: 6 weeks post op
Secondary outcomes (1)
rate of contamination of surgical field by stool during surgery
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CleansingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Urogynecology, Ltd.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981539
- Sponsor's protocol ID
- IULTD-4747
- Status last verified
- Sep 2009
- First submitted
- 21 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?
- ClinicalTrials.gov ID
- NCT00981539
- Acronym / sponsor ID
- IULTD-4747
- Conditions
- Colon Cleansing
- Keywords
- The focus of this study is to determine whether it is beneficial to administer enemas before surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Illinois Urogynecology, Ltd.University, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 22 Sep 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.
Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.
Detailed description
The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment : receives pre operative enema | Active comparator | Procedure: enemaone arm will receive pre operative enema |
| no enema | No intervention | –this group will not receive pre operative enema |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female, AND
- undergoing vaginal surgery for prolapse.
Key exclusion criteria (4 listed)
- pregnant women,
- age younger than eighteen,
- male sex, OR
- concurrent abdominal surgery.
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 |
|---|---|---|
| enemaAlso: adult over the counter enemapre operative rectal enema one adult bottle to be used rectally the night before surgery | Procedure or surgery | treatment : receives pre operative enema |
Primary outcome
wound infection rate
Time frame: 6 weeks post op
1 secondary outcome
rate of contamination of surgical field by stool during surgery
Time frame: day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- Practice siteLink provided by the sponsor.
Related trials for Colon Cleansing
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 1/2
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
Bowel Preparation
Not yet recruitingObservational study
The Effect of pH Value of Water Consumed During Bowel Preparation Before Colonoscopy on Colon Cleansing
Colonoscopy, Bowel Cleansing
Not yet recruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Colonoscopy, Bowel Preparation
Not yet recruiting
Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing
Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enema in people with Colon Cleansing, run by Illinois Urogynecology, Ltd. at 2 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise M Elser, MD (708-499-9800, delser@iultd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infection rate (time frame: 6 weeks post op). 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 22 Sep 2009.