Mechanical Bowel Preparation for Elective Colorectal Anastomosis

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

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.

Study Overview

• Status: Completed
• Conditions: Anastomosis
• Intervention / Treatment: Drug: Polyethylene glycol

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Western Medical Center, Mexican Institute of Social Security

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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) .
No Intervention: No mechanical bowel preparation; 81 Patients who received clear liquid diet 1 day before intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Anastomotic leak	Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.	6 weeks
Number of Participants with Surgical site infection	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.	6 weeks
Number of Participants with Postoperative ileus	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.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Clotilde Fuentes, pHD, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Outcomes; Bowel preparation
• Other Study ID Numbers: F-2015 1301-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided