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

Wound Infection Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01458353
• Other study ID #: HGUElche1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 19, 2011
• Last updated: October 21, 2011
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: Hospital General Universitario Elche
• Contact: Jaime Jaime, MD, PhD
• Phone: (0034)630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Abdominal Abscess
• Intra-abdominal Abscess
• Peritoneal Contamination After Ileocolonic Anastomosis
• Wound Infection

Intervention

Procedure:
• Stapled anastomosis
Stapled anastomosis after ileocolonic resection
• Handsewn anastomosis
Handsewn anastomosis after ileocolonic resection

Locations

Country	Name	City	State
Spain	Hospital General de Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal contamination after finishing the ileocolonic anastomosis	Swabs will be obtained from the peritoneal surface for microbiological culture	1 year	No