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Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome

Primary Purpose

Colorectal Tumors

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Antibiotic lavage
Normal saline lavage
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Tumors focused on measuring recurrence

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of colon neoplasms
  • 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)
  • allergy to gentamicin or clindamycin.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antibiotic lavage

    Normal saline lavage

    Arm Description

    Peritoneal irrigation with Gentamycin - clndamycin solution

    Peritoneal irrigation with normal saline

    Outcomes

    Primary Outcome Measures

    Global survival

    Secondary Outcome Measures

    Disease free survival

    Full Information

    First Posted
    March 23, 2015
    Last Updated
    March 25, 2015
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02399059
    Brief Title
    Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome
    Official Title
    Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.
    Detailed Description
    Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Tumors
    Keywords
    recurrence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotic lavage
    Arm Type
    Experimental
    Arm Description
    Peritoneal irrigation with Gentamycin - clndamycin solution
    Arm Title
    Normal saline lavage
    Arm Type
    Active Comparator
    Arm Description
    Peritoneal irrigation with normal saline
    Intervention Type
    Procedure
    Intervention Name(s)
    Antibiotic lavage
    Intervention Description
    Peritoneal irrigation with gentamycin-clindamycin solution
    Intervention Type
    Procedure
    Intervention Name(s)
    Normal saline lavage
    Intervention Description
    Peritoneal irrigation with normal saline
    Primary Outcome Measure Information:
    Title
    Global survival
    Time Frame
    36 months after intervention
    Secondary Outcome Measure Information:
    Title
    Disease free survival
    Time Frame
    36 months after intervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of colon neoplasms 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) allergy to gentamicin or clindamycin.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaime Ruiz-Tovar, MD, PhD
    Organizational Affiliation
    Hospital Rey Juan Carlos
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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