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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01378832
Acronym
lavage
Enrollment
102
Registered
2011-06-22
Start date
2010-01-31
Completion date
2010-12-31
Last updated
2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

Intra-abdominal abscess, wound infection, colorectal surgery

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).

Interventions

PROCEDUREIntra-peritoneal antibiotic lavage

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).

Sponsors

Universidad Miguel Hernandez de Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection30 daysIntra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026