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Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01797770
Acronym
MBP
Enrollment
90
Registered
2013-02-22
Start date
2012-01-31
Completion date
2014-02-28
Last updated
2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Rectal Cancer

Keywords

mechanical bowel preparation, Colon Cancer

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.

Interventions

DRUGpolyethylene glycol

mechanical bowel preparation with polyethylene glycol one day prior to surgery

No laxatives or bowel preparation

Sponsors

PVS Memorial Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
anastomotic leak30 daysclinical/drain/radiological leak

Secondary

MeasureTime frameDescription
Intraoperative parameters assessment1 dayintraoperative assessment of tumor site, extend, operative time, intraoperative contamination
bowel recovery30 daysDay of passage of flatus or faeces
drain removal30 dayspostoperative day of drain removal
surgical site infection14 dayssuperficial and deep surgical site infection
Hospital stay30 dayspostoperative hospital stay
Readmission30daysadmission to hospital after discharge due to any reasons
Re-exploration30 daysAny intervention radiological or surgical due to procedure related complications

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026