Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome
Phase 3
Completed
- Conditions
- Colorectal Tumors
- Interventions
- Procedure: Antibiotic lavageProcedure: Normal saline lavage
- Registration Number
- NCT02399059
- Lead Sponsor
- Hospital General Universitario Elche
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibiotic lavage Antibiotic lavage Peritoneal irrigation with Gentamycin - clndamycin solution Normal saline lavage Normal saline lavage Peritoneal irrigation with normal saline
- Primary Outcome Measures
Name Time Method Global survival 36 months after intervention
- Secondary Outcome Measures
Name Time Method Disease free survival 36 months after intervention