AnastomosisPhase 3NCT02731963
Mechanical Bowel Preparation for Elective Colorectal Anastomosis
A Phase 3 study testing Polyethylene glycol in people with Anastomosis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis
- What is being tested?
- Polyethylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2014to Feb 2016
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Entitlement to the Mexican Institute of Social Security
- Signed informed consent
- Patients with colorectal pathology who needed primary elective colorectal anastomosis
- Body mass index >18, and < 31
Who cannot join
- Patients who dropped out from the study or withdrew the informed consent
- Patients who did not accepted the surgical procedure
- Patients who had been submitted to surgery before entering the protocol
- Patients who need a colostomy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340
About this study
Official title: Mechanical Bowel Preparation for Elective Colorectal Anastomosis: Randomized Clinical Trial.
Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.
Read the detailed description
Objective: Compare elective colorectal anastomosis with or without mechanical bowel preparation on outcomes, particularly anastomotic leak, surgical site infection, and ileum.
Materials and methods: A clinical trial was conducted including patients with colorectal pathology who underwent elective colorectal anastomosis. Patients were randomized into two groups; with mechanical bowel preparation (Group 1), and without mechanical bowel preparation (Group 2). Surgical, and non-surgical outcomes were evaluated, including anastomotic leak, surgical site infection, ileum, acute kidney injury, pneumonia, and mortality.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. Inferential analysis with student's t-test, and/or Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.
- Conditions
- Anastomosis
- Being tested
- Polyethylene glycol
- Keywords
- Outcomes, Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycolDrug
Patients with colorectal pathology who underwent elective colorectal anastomosis, that were randomized into two groups; one of them received mechanical bowel preparation with polyethylene glycol (study group), and the other one received clear liquid diet(control group) .
| Study group | Role | What they receive |
|---|---|---|
| Mechanical bowel preparation | Experimental | 80 Patients who received mechanical bowel preparation with 4 packets of polyethylene glycol in 4 liters of water, 4 hours before intervention. Receives: Drug: Polyethylene glycol |
| No mechanical bowel preparation | No intervention | 81 Patients who received clear liquid diet 1 day before intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Anastomotic leak
Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.
Measured: 6 weeks
Number of Participants with Surgical site infection
Following the surgical procedure, surgical site infection was evaluated if the patient presented specific signs and symptoms for this condition (redness, delayed healing, fever, pain, tenderness, warmth, or swelling), and confirmation with culture of the purulent discharge.
Measured: 6 weeks
Number of Participants with Postoperative ileus
Following the surgical procedure, ileus was evaluated if the patient presented distended and tympanic abdomen, and absence or hypoactive bowel sounds, and confirmed with a plain abdominal radiography.
Measured: 6 weeks
Secondary outcomes (5)
Number of Participants with Fistula
Following the surgical procedure, fistula was evaluated with fecal discharge on drainage and confirmed with CT fistulography.
Measured: 6 weeks
Number of Participants with Abdominal sepsis
Following the surgical procedure, abdominal sepsis was evaluated if the patient presented specific signs and symptoms for this condition (fever, abdominal pain, ascites, worsening), and confirmation with computerized tomography.
Measured: 6 weeks
Number of Participants with Abscess
Following the surgical procedure, abscesses were evaluated if the patient presented specific signs and symptoms for this condition (fever, abdominal pain, ascites), and confirmation with computerized tomography.
Measured: 6 weeks
Number of Participants with Pneumonia
Following the surgical procedure, pneumonia was evaluated if the patient presented specific signs and symptoms for this condition (fever, shaking chills, cough productive of sputum), and confirmation with chest radiography.
Measured: 6 weeks
Number of Participants with Acute kidney injury
Following the surgical procedure, acute kidney injury was evaluated with kidney function studies (BUN, creatinine)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnastomosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social
- Investigators
- Clotilde Fuentes, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731963
- Sponsor's protocol ID
- F-2015 1301-18
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation for Elective Colorectal Anastomosis: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02731963
- Acronym / sponsor ID
- F-2015 1301-18
- Conditions
- Anastomosis
- Keywords
- Outcomes, Bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Apr 2016 (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.
Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.
Detailed description
Objective: Compare elective colorectal anastomosis with or without mechanical bowel preparation on outcomes, particularly anastomotic leak, surgical site infection, and ileum.
Materials and methods: A clinical trial was conducted including patients with colorectal pathology who underwent elective colorectal anastomosis. Patients were randomized into two groups; with mechanical bowel preparation (Group 1), and without mechanical bowel preparation (Group 2). Surgical, and non-surgical outcomes were evaluated, including anastomotic leak, surgical site infection, ileum, acute kidney injury, pneumonia, and mortality.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. Inferential analysis with student's t-test, and/or Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical bowel preparation | Experimental | Drug: Polyethylene glycol80 Patients who received mechanical bowel preparation with 4 packets of polyethylene glycol in 4 liters of water, 4 hours before intervention. |
| No mechanical bowel preparation | No intervention | –81 Patients who received clear liquid diet 1 day before intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Entitlement to the Mexican Institute of Social Security
- Signed informed consent
- Patients with colorectal pathology who needed primary elective colorectal anastomosis
- Body mass index >18, and < 31
Key exclusion criteria (4 listed)
- Patients who dropped out from the study or withdrew the informed consent
- Patients who did not accepted the surgical procedure
- Patients who had been submitted to surgery before entering the protocol
- Patients who need a colostomy
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 |
|---|---|---|
| Polyethylene glycolPatients with colorectal pathology who underwent elective colorectal anastomosis, that were randomized into two groups; one of them received mechanical bowel preparation with polyethylene glycol (study group), and the other one received clear liquid diet(control group) . | Drug | Mechanical bowel preparation |
Primary outcome
Number of Participants with Anastomotic leak
Time frame: 6 weeks
Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.
Number of Participants with Surgical site infection
Time frame: 6 weeks
Following the surgical procedure, surgical site infection was evaluated if the patient presented specific signs and symptoms for this condition (redness, delayed healing, fever, pain, tenderness, warmth, or swelling), and confirmation with culture of the purulent discharge.
Number of Participants with Postoperative ileus
Time frame: 6 weeks
Following the surgical procedure, ileus was evaluated if the patient presented distended and tympanic abdomen, and absence or hypoactive bowel sounds, and confirmed with a plain abdominal radiography.
5 secondary outcomes
Number of Participants with Fistula
Time frame: 6 weeks
Number of Participants with Abdominal sepsis
Time frame: 6 weeks
Number of Participants with Abscess
Time frame: 6 weeks
Number of Participants with Pneumonia
Time frame: 6 weeks
Number of Participants with Acute kidney injury
Time frame: 6 weeks
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 8 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Clotilde Fuentes, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene glycol in people with Anastomosis, run by Instituto Mexicano del Seguro Social 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 4 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: finished, as of the sponsor's last update on 8 Apr 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Anastomotic leak (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 8 Apr 2016.