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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01458353
Other study ID # HGUElche1
Secondary ID
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


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
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