Functional Disorder of IntestineNCT01044212
Bowel Function After Minimally Invasive Urogynecologic Surgery
A study testing Docusate and Bowel medications in people with Functional Disorder of Intestine, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Disorder of Intestine
- What is being tested?
- Docusate and Bowel medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.
- Procedures may include:
- robot-assisted laparoscopic sacrocolpopexy
- sacrospinous ligament suspension
- uterosacral ligament suspension/paravaginal defect repair
- colpocleisis
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- cystocele repair
- Additional procedures may include:
- hysterectomy
- adnexectomy
- culdoplasty
- minimally invasive sling procedure (TVT or TOT)
- periurethral collagen injections
- enterocele repair
Who cannot join
- Planning to undergo laparotomy.
- Undergoing rectocele or perineocele repair as part of surgery.
- Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
- Presence of a colostomy.
- Chronic kidney disease
- Insulin-dependent diabetes mellitus
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- Known cardiac disease
- Gastric ulcers
- Difficulty swallowing or esophageal stricture
- Persistent nausea and vomiting
- Signs and symptoms consistent with bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
Read the detailed description
See above
- Conditions
- Functional Disorder of Intestine
- Being tested
- Docusate, Bowel medications
- Keywords
- Urogynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocusateDrug
Also called Colace
Docusate 100mg BID
Bowel medicationsDrug
Also called Colace, Psyllium, Polyethylene glycol, Dulcolax
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
| Study group | Role | What they receive |
|---|---|---|
| Docusate | Active comparator | Docusate is the standard of care regimen Receives: Drug: Docusate |
| Bowel medications | Experimental | Docusate, Miralax, Metamucil wafers, Bisacodyl suppository Receives: Drug: Bowel medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Post-op Bowel Movement
The time to first post-operative bowel movement was measured in hours after surgery.
Measured: Within 1 week of surgery
Secondary outcomes (2)
Pain Level Associated With First Postoperative Bowel Movement
The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.
Measured: Within 1 week of surgery
Consistency of First Postoperative Bowel Movement
The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.
The seven types of stool are:
Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid
Measured: Within 1 week of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Disorder of IntestineStudies 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunhilde Buchsbaum, University of Rochester
- Investigators
- Gunhilde Buchsbaum, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044212
- Sponsor's protocol ID
- 29359
- Status last verified
- Sep 2015
- First submitted
- 5 Jan 2010
- Last updated
- 21 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01044212
- Acronym / sponsor ID
- 29359
- Conditions
- Functional Disorder of Intestine
- Keywords
- Urogynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 21 Oct 2015
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 assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
Detailed description
See above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docusate | Active comparator | Drug: DocusateDocusate is the standard of care regimen |
| Bowel medications | Experimental | Drug: Bowel medicationsDocusate, Miralax, Metamucil wafers, Bisacodyl suppository |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.
- robot-assisted laparoscopic sacrocolpopexy
- sacrospinous ligament suspension
- uterosacral ligament suspension/paravaginal defect repair
- colpocleisis
Key exclusion criteria (11 listed)
- Planning to undergo laparotomy.
- Undergoing rectocele or perineocele repair as part of surgery.
- Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
- Presence of a colostomy.
- Chronic kidney disease
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 |
|---|---|---|
| DocusateAlso: ColaceDocusate 100mg BID | Drug | Docusate |
| Bowel medicationsAlso: Colace, Psyllium, Polyethylene glycol, DulcolaxDocusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID | Drug | Bowel medications |
Primary outcome
Time to First Post-op Bowel Movement
Time frame: Within 1 week of surgery
The time to first post-operative bowel movement was measured in hours after surgery.
2 secondary outcomes
Pain Level Associated With First Postoperative Bowel Movement
Time frame: Within 1 week of surgery
Consistency of First Postoperative Bowel Movement
Time frame: Within 1 week of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gunhilde Buchsbaum, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docusate and Bowel medications in people with Functional Disorder of Intestine, run by University of Rochester 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 14 inclusion and 11 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 21 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to First Post-op Bowel Movement (time frame: Within 1 week of surgery). 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 21 Oct 2015.