Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

• Conditions: Rectal Cancer; Colon Cancer
• Interventions: Drug: polyethylene glycol; Other: No Preparation

• Registration Number: NCT01797770
• Lead Sponsor: PVS Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-16
• Status Verified: 2013-02
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-22
• Last Update Posted: 2013-02-22
• Primary Completion: 2014-01
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanical bowel preperation	polyethylene glycol	mechanical bowel preparation with polyethylene glycol one day prior to surgery
Mechanical bowel preperation	No Preparation	mechanical bowel preparation with polyethylene glycol one day prior to surgery

Primary Outcome Measures

Name	Time	Method
anastomotic leak	30 days	clinical/drain/radiological leak

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PVS Memorial Hospital; 🇮🇳 Kochi, Kerala, India