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

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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Key information

Conditions

Colorectal Tumors Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Recurrence

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibiotic lavage

Procedure

Peritoneal irrigation with gentamycin-clindamycin solution

Normal saline lavage

Procedure

Peritoneal irrigation with normal saline

Primary outcomes

Global survival

Time frame: 36 months after intervention

Secondary outcomes

Disease free survival

Time frame: 36 months after intervention

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Mar 26, 2015
Registry last updated: Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed