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

H

Hospital General Universitario Elche

Status and phase

Unknown
Phase 3

Conditions

Peritoneal Contamination After Ileocolonic Anastomosis
Intra-abdominal Abscess
Wound Infection

Treatments

Procedure: Handsewn anastomosis
Procedure: Stapled anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT01458353
HGUElche1

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Handsewn ileocolonic anastomosis
Experimental group
Description:
Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
Treatment:
Procedure: Handsewn anastomosis
Stapled ileocolonic anastomosis
Experimental group
Description:
Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
Treatment:
Procedure: Stapled anastomosis

Trial contacts and locations

1

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Central trial contact

Jaime Jaime, MD, PhD

Data sourced from clinicaltrials.gov

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