Effect of Peritoneal Lavage With Clindamycin-Gentamicin S... | NCT02399059

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

NCT02399059

Sponsor

Hospital General Universitario Elche

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

106Actual

Phase

Phase 3

Conditions

Colorectal Tumors

Interventions

Antibiotic lavage
Normal saline lavage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antibiotic lavage	Experimental	Peritoneal irrigation with Gentamycin - clndamycin solution	Procedure: Antibiotic lavage
Normal saline lavage	Active Comparator	Peritoneal irrigation with normal saline	Procedure: Normal saline lavage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic lavage	Procedure	Peritoneal irrigation with gentamycin-clindamycin solution	Antibiotic lavage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global survival		36 months after intervention

Secondary Outcomes

Measure	Description	Time Frame
Disease free survival		36 months after intervention

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaime Ruiz-Tovar, MD, PhD	Hospital Rey Juan Carlos	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided