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
About this trial
This is an interventional prevention trial for Colorectal Tumors focused on measuring recurrence
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.
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
NCT ID
NCT02399059
First Posted
March 23, 2015
Last Updated
March 25, 2015
Sponsor
Hospital General Universitario Elche
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
Learn more about this trial
Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome
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