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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378832
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Information provided by:
Universidad Miguel Hernandez de Elche

Brief Summary:
Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Procedure: Intra-peritoneal antibiotic lavage Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Intervention Details:
  • Procedure: Intra-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).

Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 30 days ]
    Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jaime Ruiz-Tovar, Universidad Miguel Hernandez de Elche Identifier: NCT01378832     History of Changes
Other Study ID Numbers: jruiztovar
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: January 2010
Keywords provided by Universidad Miguel Hernandez de Elche:
Intra-abdominal abscess
wound infection
colorectal surgery
Additional relevant MeSH terms:
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Clindamycin palmitate
Clindamycin phosphate
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Pharmaceutical Solutions
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action