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Completed

NCT Number: NCT02731963

Mechanical Bowel Preparation for Elective Colorectal Anastomosis

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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Key information

Conditions

Anastomosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol

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) .

Primary outcomes

  1. Number of Participants with Anastomotic leak

    Time frame: 6 weeks

    Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.

  2. Number of Participants with Surgical site infection

    Time frame: 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.

  3. Number of Participants with Postoperative ileus

    Time frame: 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.

Secondary outcomes

  1. Number of Participants with Fistula

    Time frame: 6 weeks

    Following the surgical procedure, fistula was evaluated with fecal discharge on drainage and confirmed with CT fistulography.

  2. Number of Participants with Abdominal sepsis

    Time frame: 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.

  3. Number of Participants with Abscess

    Time frame: 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.

  4. Number of Participants with Pneumonia

    Time frame: 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.

  5. Number of Participants with Acute kidney injury

    Time frame: 6 weeks

    Following the surgical procedure, acute kidney injury was evaluated with kidney function studies (BUN, creatinine)

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2016
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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