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Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome

Information source: Hospital General Universitario Elche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Tumors

Intervention: Antibiotic lavage (Procedure); Normal saline lavage (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Hospital General Universitario Elche

Official(s) and/or principal investigator(s):
Jaime Ruiz-Tovar, MD, PhD, Principal Investigator, Affiliation: Hospital Rey Juan Carlos

Summary

Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.

Clinical Details

Official title: Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Global survival

Secondary outcome: Disease free survival

Detailed description: Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of colon neoplasms

- plans to undergo an elective surgery with curative aims

Exclusion Criteria:

- preoperative diagnosis of chronic renal failure (because of the risk of

nephrotoxicity associated with intraperitoneal gentamicin absorption)

- allergy to gentamicin or clindamycin.

Locations and Contacts

Additional Information

Starting date: January 2011
Last updated: March 25, 2015

Page last updated: August 23, 2015

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