Pre-operative Bowel PrepNCT01512394
Pre-op Bowel Prep Before Abdominal Surgery
A study testing standard bowel prep and no bowel prep in people with Pre-operative Bowel Prep, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Current management of elective bowel surgery typically involves performing a preoperative bowel preparation ("bowel prep") in many instances; however, this practice is not standardized at most institutions. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Pre-operative Bowel Prep
- What is being tested?
- standard bowel prep and no bowel prep
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2013
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children, ages 3 months to 17 years, who will undergo an elective bowel resection or ostomy closure at CMH
Who cannot join
- Patients whose operation was performed emergently, and hence a bowel prep was not possible preoperatively;
- If they necessitate a diverting proximal ostomy;
- If they have any known intra-abdominal infection preoperatively;
- If an intra-operative colonoscopy is necessary, and hence the patient must have a preoperative bowel prep.
- No patients with an underlying malignancy or immunodeficiency or with renal, metabolic or cardiac conditions will be included.
- No patients with known allergies to any medication used in the bowel preparation will be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
Current management of elective bowel surgery typically involves performing a preoperative bowel preparation ("bowel prep") in many instances; however, this practice is not standardized at most institutions. Over the years, bowel preps have been used in an attempt to decrease the risk of complications associated with gastrointestinal surgery. However, there is limited adequate data to support this clinical management in the pediatric patient population. The investigator plans to perform a prospective, randomized study of our pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to assess if a bowel prep prior to surgical intervention affects their postoperative course. The aim of this study is to evaluate for differences that may alter and improve future management.
Read the detailed description
At CMH, our current approach to preoperative management for elective intestinal surgery is not standardized amongst our Pediatric Surgical attendings. There are seven different attendings, each of whom individually dictates if a patient is to undergo a preoperative bowel prep, and if so, which bowel prep will be used. This is no different than the majority of practices across the US, including adult and pediatric patient populations. The aim of this study, therefore, is to standardize our current management and assess if the presence or absence of a preoperative bowel prep has an effect on post-operative outcomes. The goal is to evaluate the effect of the bowel preparation not the surgical procedure itself.
- Conditions
- Pre-operative Bowel Prep
- Being tested
- standard bowel prep, no bowel prep
- Keywords
- bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard bowel prepProcedure or surgery
standard bowel prep
no bowel prepProcedure or surgery
no bowel prep
| Study group | Role | What they receive |
|---|---|---|
| Standard bowel prep | Active comparator | Standard bowel prep Receives: Procedure: standard bowel prep |
| No bowel prep | Experimental | No bowel prep Receives: Procedure: no bowel prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications following surgery
compications such as infection, leaks, obstruction etc
Measured: 6 weeks
Secondary outcomes (1)
Length of hospital stay
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013 (estimated)
Why it stopped: Study was never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-operative Bowel PrepStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512394
- Sponsor's protocol ID
- 11 09-139
- Status last verified
- Jan 2016
- First submitted
- 13 Dec 2011
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
- ClinicalTrials.gov ID
- NCT01512394
- Acronym / sponsor ID
- 11 09-139
- Conditions
- Pre-operative Bowel Prep
- Keywords
- bowel preparation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of North Carolina
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Jan 2012 (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.
Current management of elective bowel surgery typically involves performing a preoperative bowel preparation ("bowel prep") in many instances; however, this practice is not standardized at most institutions. Over the years, bowel preps have been used in an attempt to decrease the risk of complications associated with gastrointestinal surgery. However, there is limited adequate data to support this clinical management in the pediatric patient population. The investigator plans to perform a prospective, randomized study of our pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to assess if a bowel prep prior to surgical intervention affects their postoperative course. The aim of this study is to evaluate for differences that may alter and improve future management.
Detailed description
At CMH, our current approach to preoperative management for elective intestinal surgery is not standardized amongst our Pediatric Surgical attendings. There are seven different attendings, each of whom individually dictates if a patient is to undergo a preoperative bowel prep, and if so, which bowel prep will be used. This is no different than the majority of practices across the US, including adult and pediatric patient populations. The aim of this study, therefore, is to standardize our current management and assess if the presence or absence of a preoperative bowel prep has an effect on post-operative outcomes. The goal is to evaluate the effect of the bowel preparation not the surgical procedure itself.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard bowel prep | Active comparator | Procedure: standard bowel prepStandard bowel prep |
| No bowel prep | Experimental | Procedure: no bowel prepNo bowel prep |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children, ages 3 months to 17 years, who will undergo an elective bowel resection or ostomy closure at CMH
Key exclusion criteria (6 listed)
- Patients whose operation was performed emergently, and hence a bowel prep was not possible preoperatively;
- If they necessitate a diverting proximal ostomy;
- If they have any known intra-abdominal infection preoperatively;
- If an intra-operative colonoscopy is necessary, and hence the patient must have a preoperative bowel prep.
- No patients with an underlying malignancy or immunodeficiency or with renal, metabolic or cardiac conditions will be included.
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 |
|---|---|---|
| standard bowel prepstandard bowel prep | Procedure or surgery | Standard bowel prep |
| no bowel prepno bowel prep | Procedure or surgery | No bowel prep |
Primary outcome
complications following surgery
Time frame: 6 weeks
compications such as infection, leaks, obstruction etc
1 secondary outcome
Length of hospital stay
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Related trials for Pre-operative Bowel Prep
Not yet recruitingObservational study
Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC
Anal Fistula, Fistula in Ano
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Recruiting
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
Active, not recruitingPhase 4
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery
Elective Colon Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard bowel prep and no bowel prep in people with Pre-operative Bowel Prep, run by Children's Mercy Hospital Kansas City 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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Jan 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
complications following surgery (time frame: 6 weeks). 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 28 Jan 2016.