Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome

Detailed Description
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In this prospective randomized trial,patients were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome following elective laparoscopic surgery for left sided colon and rectal tumors. Randomization is done from the out -patient department at the time of admission, using random numbers from a computer generated list from a sealed envelope method. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with polyethylene glycol one day prior to surgery. Both groups will have the scheduled laparoscopic colonic resections. Use of diverting stoma is left to the discretion of the operating surgeon. Cases that needed a diverting stoma, will be analyzed separately.

Official Title
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A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours

Conditions
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Rectal Cancer, Colon Cancer

Intervention / Treatment
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* Drug: polyethylene glycol
* Other: No Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: left sided colonic and rectal tumors eligible for elective laparoscopic surgery Exclusion Criteria: Patients with intestinal obstruction or perforation. patients with T4b tumors. metastatic tumors patients with multiple previous abdominal surgeries

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical bowel preperation<br>mechanical bowel preparation with polyethylene glycol one day prior to surgery | Drug: polyethylene glycol<br>* mechanical bowel preparation with polyethylene glycol one day prior to surgery<br>Other: No Preparation<br>* No laxatives or bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leak | clinical/drain/radiological leak | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection | superficial and deep surgical site infection | 14 days | 
| Intraoperative parameters assessment | intraoperative assessment of tumor site, extend, operative time, intraoperative contamination | 1 day | 
| bowel recovery | Day of passage of flatus or faeces | 30 days | 
| drain removal | postoperative day of drain removal | 30 days | 
| Re-exploration | Any intervention radiological or surgical due to procedure related complications | 30 days | 
| Hospital stay | postoperative hospital stay | 30 days | 
| Readmission | admission to hospital after discharge due to any reasons | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical bowel preparation, Colon Cancer