Back to resultsMicrobiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer
Primary Purpose
Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection, Intra-abdominal Abscess
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Stapled anastomosis
Handsewn anastomosis
Sponsored by
About this trial
This is an interventional basic science trial for Peritoneal Contamination After Ileocolonic Anastomosis focused on measuring Right-sided colon cancer, Ileocolonic anastomosis, stapled anastomosis, handsewn anastomosis, peritoneal contamination, microbiological spectrum
Eligibility Criteria
Inclusion Criteria:
- diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Sites / Locations
- Hospital General de Elche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Handsewn ileocolonic anastomosis
Stapled ileocolonic anastomosis
Arm Description
Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
Outcomes
Primary Outcome Measures
Peritoneal contamination after finishing the ileocolonic anastomosis
Swabs will be obtained from the peritoneal surface for microbiological culture
Secondary Outcome Measures
Full Information
NCT ID
NCT01458353
First Posted
October 19, 2011
Last Updated
October 21, 2011
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT01458353
Brief Title
Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer
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?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection, Intra-abdominal Abscess
Keywords
Right-sided colon cancer, Ileocolonic anastomosis, stapled anastomosis, handsewn anastomosis, peritoneal contamination, microbiological spectrum
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Handsewn ileocolonic anastomosis
Arm Type
Experimental
Arm Description
Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
Arm Title
Stapled ileocolonic anastomosis
Arm Type
Experimental
Arm Description
Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
Intervention Type
Procedure
Intervention Name(s)
Stapled anastomosis
Intervention Description
Stapled anastomosis after ileocolonic resection
Intervention Type
Procedure
Intervention Name(s)
Handsewn anastomosis
Intervention Description
Handsewn anastomosis after ileocolonic resection
Primary Outcome Measure Information:
Title
Peritoneal contamination after finishing the ileocolonic anastomosis
Description
Swabs will be obtained from the peritoneal surface for microbiological culture
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Jaime, MD, PhD
Phone
(0034)630534808
Email
jruiztovar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar, MD, PhD
Organizational Affiliation
Hospital General de Elche
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Arroyo, MD, PhD
Organizational Affiliation
Hospital General de Elche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar, MD, PhD
Phone
(0034)630534808
Email
jruiztovar@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22581209
Citation
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.
Results Reference
derived
Learn more about this trial
Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer
We'll reach out to this number within 24 hrs