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

Colorectal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399059
• Other study ID #: HURJ2015-01
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2015
• Last updated: March 25, 2015
• Start date: January 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Tumors

Intervention

Procedure:
• Antibiotic lavage
Peritoneal irrigation with gentamycin-clindamycin solution
• Normal saline lavage
Peritoneal irrigation with normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global survival		36 months after intervention	No
Secondary	Disease free survival		36 months after intervention	No