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Clinical Trials/NCT01458353
NCT01458353UnknownPhase 3

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?

Hospital General Universitario Elche2 sites in 1 country80 target enrollmentStarted: November 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Peritoneal contamination after finishing the ileocolonic anastomosis

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Peritoneal contamination after finishing the ileocolonic anastomosis

Time Frame: 1 year

Swabs will be obtained from the peritoneal surface for microbiological culture

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital General Universitario Elche
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaime Ruiz-Tovar, MD, PhD

Doctor in Surgery by Universidad Autonoma de Madrid (Spain)

Hospital General Universitario Elche

Study Sites (2)

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