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

M

Miguel Hernández University of Elche

Status and phase

Completed
Phase 3

Conditions

Surgical Site Infection

Treatments

Procedure: Intra-peritoneal antibiotic lavage

Study type

Interventional

Funder types

Other

Identifiers

NCT01378832
jruiztovar

Details and patient eligibility

About

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

Full 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).

Enrollment

102 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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