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

NCT01378832 | Completed Phase 3

• 1 other identifier: jruiztovar
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

Conditions

Surgical Site Infection

Keywords

Intra-abdominal abscess; wound infection; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

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

  30 days

Interventions

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.

You may not qualify if:

• preoperative diagnosis of chronic renal failure, because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption
• an anastomotic leak in the postoperative course

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Related Publications (1)

• Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.

  PMID: 22265220 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Abdominal Abscess; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abscess; Suppuration

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 22, 2011

Record last verified: 2010-01