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

Phase 3

• Conditions: Peritoneal Contamination After Ileocolonic Anastomosis; Wound Infection; Intra-abdominal Abscess
• Interventions: Procedure: Handsewn anastomosis; Procedure: Stapled anastomosis

• Registration Number: NCT01458353
• Lead Sponsor: Hospital General Universitario Elche

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-21
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-24
• Last Update Posted: 2011-10-24
• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handsewn ileocolonic anastomosis	Handsewn anastomosis	Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
Stapled ileocolonic anastomosis	Stapled anastomosis	Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis

Primary Outcome Measures

Name	Time	Method
Peritoneal contamination after finishing the ileocolonic anastomosis	1 year	Swabs will be obtained from the peritoneal surface for microbiological culture

Trial Locations

Locations (1)

Hospital General de Elche; 🇪🇸 Elche, Alicante, Spain