Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer

October 21, 2011 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer: Are There Differences in the Peritoneal Contamination After Performing a Stapled or a Handsewn Anastomosis?

Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.

Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital General de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Handsewn ileocolonic anastomosis
Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
Procedure: Handsewn anastomosis
Handsewn anastomosis after ileocolonic resection
Experimental: Stapled ileocolonic anastomosis
Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
Procedure: Stapled anastomosis
Stapled anastomosis after ileocolonic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritoneal contamination after finishing the ileocolonic anastomosis
Time Frame: 1 year
Swabs will be obtained from the peritoneal surface for microbiological culture
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Hospital General de Elche
  • Study Director: Antonio Arroyo, MD, PhD, Hospital General de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGUElche1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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