Colorectal Tumors
Conditions
Keywords
recurrence
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.
Interventions
PROCEDUREAntibiotic lavage
Peritoneal irrigation with gentamycin-clindamycin solution
PROCEDURENormal saline lavage
Peritoneal irrigation with normal saline
Sponsors
Hospital General Universitario Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global survival | 36 months after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 36 months after intervention |
Outcome results
None listed