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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intra-peritoneal antibiotic lavage
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Intra-abdominal abscess, wound infection, colorectal surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2011
    Last Updated
    June 21, 2011
    Sponsor
    Universidad Miguel Hernandez de Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01378832
    Brief Title
    Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery
    Acronym
    lavage
    Official Title
    Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universidad Miguel Hernandez de Elche

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Site Infection
    Keywords
    Intra-abdominal abscess, wound infection, colorectal surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Intra-peritoneal antibiotic lavage
    Intervention Description
    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 Measure Information:
    Title
    Surgical site infection
    Description
    Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22265220
    Citation
    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.
    Results Reference
    derived

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

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