Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Anastomosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731963
• Other study ID #: F-2015 1301-18
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2016
• Last updated: April 7, 2016
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anastomosis

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) .

Locations

Country	Name	City	State
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Number of Participants with Fistula	Following the surgical procedure, fistula was evaluated with fecal discharge on drainage and confirmed with CT fistulography.	6 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Number of Participants with Acute kidney injury	Following the surgical procedure, acute kidney injury was evaluated with kidney function studies (BUN, creatinine)	6 weeks	Yes