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

• Sponsor: Hospital General Universitario Elche (Other)
• Overall Status: Completed
• CT.gov ID: NCT02399059
• Collaborator: (none)
• Enrollment: 106
• Arms: 2
• Duration (Months): 49.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Tumors	Procedure: Antibiotic lavage; Procedure: Normal saline lavage	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antibiotic lavage Peritoneal irrigation with Gentamycin - clndamycin solution	Procedure: Antibiotic lavage; Peritoneal irrigation with gentamycin-clindamycin solution
Active Comparator: Normal saline lavage Peritoneal irrigation with normal saline	Procedure: Normal saline lavage; Peritoneal irrigation with normal saline

Outcome Measures

Primary Outcome Measures

1. Global survival [36 months after intervention]

Secondary Outcome Measures

1. Disease free survival [36 months after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital General Universitario Elche

Investigators

• Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Hospital Rey Juan Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche
• ClinicalTrials.gov Identifier: NCT02399059
• Other Study ID Numbers: HURJ2015-01
• First Posted: Mar 26, 2015
• Last Update Posted: Mar 26, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche: recurrence
• Additional relevant MeSH terms: Colorectal Neoplasms; Anti-Bacterial Agents

Study Results

No Results Posted as of Mar 26, 2015