NCT02731963

Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Mechanical Bowel Preparation for Elective Colorectal Anastomosis: Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomosis

Interventions

Type	Name	Description
DRUG	Polyethylene glycol	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) .

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-02-01
• Completion: 2016-02-01
• First posted: 2016-04-08
• Last updated: 2016-04-08

Locations

1 site across 1 country: Mexico