Clinical trial NCT02731963: Mechanical Bowel Preparation for Elective Colorectal Anastomosis
Official title: Mechanical Bowel Preparation for Elective Colorectal Anastomosis: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anastomosis
Keywords: Outcomes
Bowel preparation
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2016-04-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants with Anastomotic leak
timeFrame: 6 weeks
measure: Number of Participants with Surgical site infection
timeFrame: 6 weeks
measure: Number of Participants with Postoperative ileus
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants with Fistula
timeFrame: 6 weeks
measure: Number of Participants with Abdominal sepsis
timeFrame: 6 weeks
measure: Number of Participants with Abscess
timeFrame: 6 weeks
measure: Number of Participants with Pneumonia
timeFrame: 6 weeks
measure: Number of Participants with Acute kidney injury
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Clotilde Fuentes, PhD
role: PRINCIPAL_INVESTIGATOR
References: