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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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