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

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ClinicalTrials.gov Identifier: NCT02399059
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.

Condition or disease Intervention/treatment Phase
Colorectal Tumors Procedure: Antibiotic lavage Procedure: Normal saline lavage Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome
Study Start Date : January 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: Antibiotic lavage
Peritoneal irrigation with Gentamycin - clndamycin solution
Procedure: Antibiotic lavage
Peritoneal irrigation with gentamycin-clindamycin solution

Active Comparator: Normal saline lavage
Peritoneal irrigation with normal saline
Procedure: Normal saline lavage
Peritoneal irrigation with normal saline




Primary Outcome Measures :
  1. Global survival [ Time Frame: 36 months after intervention ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 36 months after intervention ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399059


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital Rey Juan Carlos

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02399059     History of Changes
Other Study ID Numbers: HURJ2015-01
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche:
recurrence
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Gentamicins
Antibiotics, Antitubercular
Pharmaceutical Solutions
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action