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

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

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Key information

Conditions

Surgical Site Infection Abdominal Abscess Abscess Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Suppuration Surgical Wound Infection Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-peritoneal antibiotic lavage

Procedure

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 outcomes

Surgical site infection

Time frame: 30 days

Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Registry information

Official study title

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

Acronym: lavage

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 22, 2011
Registry last updated: Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed