Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery

Phase 3

Completed

• Conditions: Surgical Site Infection

• Registration Number: NCT01378832
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

Detailed Description

A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-21
• Last Update Submitted: 2011-06-21
• Study First Posted: 2011-06-22
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• diagnosis of colorectal neoplasms and 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
• an anastomotic leak in the postoperative course

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery