Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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

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Anastomosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mechanical bowel preparation

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

Group Type EXPERIMENTAL

Polyethylene glycol

Intervention Type DRUG

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) .

No mechanical bowel preparation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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) .

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No