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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Colorectal Tumors

Treatments: Procedure: Antibiotic lavage; Procedure: Normal saline lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT02399059

HURJ2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Antibiotic lavage

Experimental group

Description:

Peritoneal irrigation with Gentamycin - clndamycin solution

Treatment:

Procedure: Antibiotic lavage

Normal saline lavage

Active Comparator group

Description:

Peritoneal irrigation with normal saline

Treatment:

Procedure: Normal saline lavage