A Phase 3 interventional study of Polyethylene glycol in Anastomosis, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by Instituto Mexicano del Seguro Social · Phase 3, Interventional, and Prevention
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.
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.
Instituto Mexicano del Seguro Social is the lead sponsor of 124 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
81 Patients who received clear liquid diet 1 day before intervention.
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) .
Number of Participants with Anastomotic leak
Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Number of Participants with Fistula
Following the surgical procedure, fistula was evaluated with fecal discharge on drainage and confirmed with CT fistulography.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Number of Participants with Acute kidney injury
Following the surgical procedure, acute kidney injury was evaluated with kidney function studies (BUN, creatinine)
Time frame: 6 weeks
Plan to share: Undecided
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Instituto Mexicano del Seguro Social