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

NCT ID: NCT01458353

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Contamination After Ileocolonic Anastomosis Wound Infection Intra-abdominal Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Handsewn ileocolonic anastomosis

Swabs obtained from patients undergoing handsewn ileocolonic anastomosis

Group Type EXPERIMENTAL

Handsewn anastomosis

Intervention Type PROCEDURE

Handsewn anastomosis after ileocolonic resection

Stapled ileocolonic anastomosis

Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis

Group Type EXPERIMENTAL

Stapled anastomosis

Intervention Type PROCEDURE

Stapled anastomosis after ileocolonic resection

Interventions

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Stapled anastomosis

Stapled anastomosis after ileocolonic resection

Intervention Type PROCEDURE

Handsewn anastomosis

Handsewn anastomosis after ileocolonic resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Doctor in Surgery by Universidad Autonoma de Madrid (Spain)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Elche

Antonio Arroyo, MD, PhD

Role: STUDY_DIRECTOR

Hospital General de Elche

Locations

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Hospital General de Elche

Elche, Alicante, Spain

Site Status

Countries

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Spain

Central Contacts

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Jaime Jaime, MD, PhD

Role: CONTACT

[email protected]
(0034)630534808

Facility Contacts

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Jaime Ruiz-Tovar, MD, PhD

Role: primary

[email protected]
(0034)630534808

References

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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.

Reference Type DERIVED
PMID: 22581209 (View on PubMed)

Other Identifiers

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HGUElche1

Identifier Type: -

Identifier Source: org_study_id