ColostomyNCT02530346
Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
A study testing No Mechanical Bowel Preparation and Mechanical Bowel Preparation in people with Colostomy and Surgical Anastomosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Colostomy, Surgical Anastomosis
- What is being tested?
- No Mechanical Bowel Preparation and Mechanical Bowel Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2015to Dec 2019
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients who are to be submitted to a colostomy closure
Who cannot join
- patients with more than 3 abdominal surgeries
- patients with primary or acquired immunodeficiencies (including malnourishment)
- Patients in which the distal intestine is closed in a Hartmann´s pouch
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Infantil de Mexico Federico Gomez
Mexico City, 06720
Emilio J Fernandez Portilla, MD, 52289917 ext. 2208, drejfernandez@gmail.com
About this study
This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).
Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.
Read the detailed description
Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.
However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.
Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.
There is not enough evidence in pediatric patients that this affirmation is also true.
- Conditions
- Colostomy, Surgical Anastomosis
- Being tested
- No Mechanical Bowel Preparation, Mechanical Bowel Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Mechanical Bowel PreparationDrug
no enemas or oral laxatives will be given in this group
Mechanical Bowel PreparationDrug
Also called Nulitelly
oral laxatives (polyethylenglycol at 100 ml/kg/dose for up to 3 times) and stoma enemas (20mlkgdo of normal saline 3 times a day) will be prescribed
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Bowel Preparation | Active comparator | Patients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery.
Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day Receives: Drug: Mechanical Bowel Preparation |
| No Mechanical Bowel Preparation | Experimental | Patients will not receive any preparation prior to surgery Receives: Drug: No Mechanical Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Related Complications
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColostomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Fernandez Portilla, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530346
- Sponsor's protocol ID
- HIM-2015-087
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2015
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02530346
- Acronym / sponsor ID
- HIM-2015-087
- Conditions
- Colostomy, Surgical Anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Aug 2015 (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.
This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).
Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.
Detailed description
Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.
However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.
Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.
There is not enough evidence in pediatric patients that this affirmation is also true.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel Preparation | Active comparator | Drug: Mechanical Bowel PreparationPatients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery. Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day |
| No Mechanical Bowel Preparation | Experimental | Drug: No Mechanical Bowel PreparationPatients will not receive any preparation prior to surgery |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients who are to be submitted to a colostomy closure
Key exclusion criteria (3 listed)
- patients with more than 3 abdominal surgeries
- patients with primary or acquired immunodeficiencies (including malnourishment)
- Patients in which the distal intestine is closed in a Hartmann´s pouch
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 |
|---|---|---|
| No Mechanical Bowel Preparationno enemas or oral laxatives will be given in this group | Drug | No Mechanical Bowel Preparation |
| Mechanical Bowel PreparationAlso: Nulitellyoral laxatives (polyethylenglycol at 100 ml/kg/dose for up to 3 times) and stoma enemas (20mlkgdo of normal saline 3 times a day) will be prescribed | Drug | Mechanical Bowel Preparation |
Primary outcome
Surgery Related Complications
Time frame: up to 30 days
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Mechanical Bowel Preparation and Mechanical Bowel Preparation in people with Colostomy and Surgical Anastomosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
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 3 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 6 Aug 2018. 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 Mexico. 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 Emilio J Fernandez Portilla, MD (52289917 ext. 2208, drejfernandez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Related Complications (time frame: up to 30 days). 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 6 Aug 2018.