Text Size

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

This study is not yet open for participant recruitment.
Verified October 2011 by Hospital General Universitario Elche
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier:
NCT01458353
First received: October 19, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Peritoneal Contamination After Ileocolonic Anastomosis
Wound Infection
Intra-abdominal Abscess
 Procedure: Stapled anastomosis
Procedure: Handsewn anastomosis
 Phase 3

Study Type: Interventional
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
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?

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hospital General Universitario Elche:

Primary Outcome Measures:
  • Peritoneal contamination after finishing the ileocolonic anastomosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Swabs will be obtained from the peritoneal surface for microbiological culture


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Handsewn ileocolonic anastomosis
Swabs obtained from patients undergoing handsewn ileocolonic anastomosis
 Procedure: Handsewn anastomosis
Handsewn anastomosis after ileocolonic resection
Experimental: Stapled ileocolonic anastomosis
Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis
 Procedure: Stapled anastomosis
Stapled anastomosis after ileocolonic resection

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458353

Contacts
Contact: Jaime Jaime, MD, PhD (0034)630534808 jruiztovar@gmail.com

Locations
Spain
Hospital General de Elche Not yet recruiting
Elche, Alicante, Spain, 03202
Contact: Jaime Ruiz-Tovar, MD, PhD     (0034)630534808     jruiztovar@gmail.com    
Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital General de Elche
Study Director: Antonio Arroyo, MD, PhD Hospital General de Elche
  More Information

No publications provided by Hospital General Universitario Elche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Doctor in Surgery by Universidad Autonoma de Madrid (Spain), Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT01458353     History of Changes
Other Study ID Numbers: HGUElche1
Study First Received: October 19, 2011
Last Updated: October 21, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital General Universitario Elche:
Right-sided colon cancer
Ileocolonic anastomosis
stapled anastomosis
 handsewn anastomosis
peritoneal contamination
microbiological spectrum

Additional relevant MeSH terms:
Abscess
Colonic Neoplasms
Wound Infection
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013