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

Phase 3

Completed

• Conditions: Colorectal Tumors

• Registration Number: NCT02399059
• Lead Sponsor: Hospital General Universitario Elche

Brief 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.

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.

Study Timeline

• Study Start: 2011-01
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Study First Posted: 2015-03-26
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global survival	36 months after intervention

Secondary Outcome Measures

Name	Time	Method
Disease free survival	36 months after intervention