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Trial record 10 of 31 for:    "Abdominal Abscess"

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

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ClinicalTrials.gov Identifier: NCT01458353
Recruitment Status : Unknown
Verified October 2011 by Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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?
Study Start Date : November 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Peritoneal contamination after finishing the ileocolonic anastomosis [ Time Frame: 1 year ]
    Swabs will be obtained from the peritoneal surface for microbiological culture

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458353

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

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
Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital General de Elche
Study Director: Antonio Arroyo, MD, PhD Hospital General de Elche

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
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011

Keywords provided by Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche:
Right-sided colon cancer
Ileocolonic anastomosis
stapled anastomosis
handsewn anastomosis
peritoneal contamination
microbiological spectrum

Additional relevant MeSH terms:
Abdominal Abscess
Colonic Neoplasms
Wound Infection
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases