NCT01797770

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

September 16, 2012

Last Update Submit

February 21, 2013

Conditions

Rectal CancerColon Cancer

Keywords

mechanical bowel preparationColon Cancer

Outcome Measures

Primary Outcomes (1)

  • anastomotic leak

    clinical/drain/radiological leak

    30 days

Secondary Outcomes (7)

  • surgical site infection

    14 days

  • Intraoperative parameters assessment

    1 day

  • bowel recovery

    30 days

  • drain removal

    30 days

  • Re-exploration

    30 days

  • +2 more secondary outcomes

Study Arms (1)

Mechanical bowel preperation

mechanical bowel preparation with polyethylene glycol one day prior to surgery

Drug: polyethylene glycolOther: No Preparation

Interventions

polyethylene glycolDRUG

mechanical bowel preparation with polyethylene glycol one day prior to surgery

Mechanical bowel preperation
No PreparationOTHER

No laxatives or bowel preparation

Mechanical bowel preperation

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Randomized open label study to assess effect of mechanical bowel preparation in elective laparoscopic surgery for left sided colon tumours

You may qualify if:

  • left sided colonic and rectal tumors
  • eligible for elective laparoscopic surgery

You may not qualify if:

  • Patients with intestinal obstruction or perforation.
  • patients with T4b tumors.
  • metastatic tumors
  • patients with multiple previous abdominal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PVS Memorial Hospital

Kochi, Kerala, 682017, India

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18156032BACKGROUND

  • 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.

    PMID: 15786427BACKGROUND

  • 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.

    PMID: 21901677BACKGROUND

  • 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.

    PMID: 21871987BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsColonic Neoplasms

Interventions

Polyethylene Glycolspreparation No. 012074

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief GI Surgeon

Study Record Dates

First Submitted

September 16, 2012

First Posted

February 22, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

IN(1)