Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Phase 3

Completed

• Conditions: Anastomosis
• Interventions: Drug: Polyethylene glycol

• Registration Number: NCT02731963
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-07
• Last Update Submitted: 2016-04-07
• Study First Posted: 2016-04-08
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Surgical site infection	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	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.
Number of Participants with Anastomotic leak	6 weeks	Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Abdominal sepsis	6 weeks	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.
Number of Participants with Abscess	6 weeks	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.
Number of Participants with Pneumonia	6 weeks	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.
Number of Participants with Acute kidney injury	6 weeks	Following the surgical procedure, acute kidney injury was evaluated with kidney function studies (BUN, creatinine)
Number of Participants with Fistula	6 weeks	Following the surgical procedure, fistula was evaluated with fecal discharge on drainage and confirmed with CT fistulography.

Trial Locations

Locations (1)

Western Medical Center, Mexican Institute of Social Security; 🇲🇽 Guadalajara, Jalisco, Mexico