Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

NCT ID: NCT01797770

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-02-28

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.

Conditions

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Rectal Cancer Colon Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanical bowel preperation

mechanical bowel preparation with polyethylene glycol one day prior to surgery

polyethylene glycol

Intervention Type DRUG

mechanical bowel preparation with polyethylene glycol one day prior to surgery

No Preparation

Intervention Type OTHER

No laxatives or bowel preparation

Interventions

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polyethylene glycol

mechanical bowel preparation with polyethylene glycol one day prior to surgery

Intervention Type DRUG

No Preparation

No laxatives or bowel preparation

Intervention Type OTHER

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PVS Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Prakash K

Chief GI Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PVS Memorial Hospital

Kochi, Kerala, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Prakash Kurumboor, MS, MCh

Role: primary

09447302588

References

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Contant CM, Hop WC, van't Sant HP, Oostvogel HJ, Smeets HJ, Stassen LP, Neijenhuis PA, Idenburg FJ, Dijkhuis CM, Heres P, van Tets WF, Gerritsen JJ, Weidema WF. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9.

Reference Type BACKGROUND
PMID: 18156032 (View on PubMed)

Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005 Apr;92(4):409-14. doi: 10.1002/bjs.4900.

Reference Type BACKGROUND
PMID: 15786427 (View on PubMed)

Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4.

Reference Type BACKGROUND
PMID: 21901677 (View on PubMed)

van't Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM. Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation. Am J Surg. 2011 Sep;202(3):321-4. doi: 10.1016/j.amjsurg.2010.10.018.

Reference Type BACKGROUND
PMID: 21871987 (View on PubMed)

Other Identifiers

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PVS2

Identifier Type: -

Identifier Source: org_study_id

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