Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 24, 2011
October 1, 2011
1.1 years
October 19, 2011
October 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peritoneal contamination after finishing the ileocolonic anastomosis
Swabs will be obtained from the peritoneal surface for microbiological culture
1 year
Study Arms (2)
Handsewn ileocolonic anastomosis
EXPERIMENTALSwabs obtained from patients undergoing handsewn ileocolonic anastomosis
Stapled ileocolonic anastomosis
EXPERIMENTALSwabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
Interventions
Stapled anastomosis after ileocolonic resection
Handsewn anastomosis after ileocolonic resection
Eligibility Criteria
You may qualify if:
- diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General de Elche
Elche, Alicante, 03202, Spain
Related Publications (1)
Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Lopez A, Frangi A, Armananzas L, Alcaide MJ, Candela F, Calpena R. 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? Int J Colorectal Dis. 2012 Nov;27(11):1515-9. doi: 10.1007/s00384-012-1492-9. Epub 2012 May 12.
PMID: 22581209DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz-Tovar, MD, PhD
Hospital General de Elche
- STUDY DIRECTOR
Antonio Arroyo, MD, PhD
Hospital General de Elche
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor in Surgery by Universidad Autonoma de Madrid (Spain)
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 24, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 24, 2011
Record last verified: 2011-10