Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery (lavage)
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intra-peritoneal antibiotic lavage
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Intra-abdominal abscess, wound infection, colorectal surgery
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Surgical site infection
Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT01378832
First Posted
June 20, 2011
Last Updated
June 21, 2011
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT01378832
Brief Title
Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery
Acronym
lavage
Official Title
Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Intra-abdominal abscess, wound infection, colorectal surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intra-peritoneal antibiotic lavage
Intervention Description
The lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3).
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
22265220
Citation
Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.
Results Reference
derived
Learn more about this trial
Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery
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