Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 3

Conditions: Anastomosis

Treatments: Drug: Polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT02731963

F-2015 1301-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Mechanical bowel preparation

Experimental group

Description:

80 Patients who received mechanical bowel preparation with 4 packets of polyethylene glycol in 4 liters of water, 4 hours before intervention.

Treatment:

Drug: Polyethylene glycol

No mechanical bowel preparation

No Intervention group

Description:

81 Patients who received clear liquid diet 1 day before intervention.