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

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Antibiotic lavage

Peritoneal irrigation with Gentamycin - clndamycin solution

Group Type EXPERIMENTAL

Antibiotic lavage

Intervention Type PROCEDURE

Peritoneal irrigation with gentamycin-clindamycin solution

Normal saline lavage

Peritoneal irrigation with normal saline

Group Type ACTIVE_COMPARATOR

Normal saline lavage

Intervention Type PROCEDURE

Peritoneal irrigation with normal saline

Interventions

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Antibiotic lavage

Peritoneal irrigation with gentamycin-clindamycin solution

Intervention Type PROCEDURE

Normal saline lavage

Peritoneal irrigation with normal saline

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No