NCT02399059

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

March 23, 2015

Last Update Submit

March 25, 2015

Conditions

Colorectal Tumors

Keywords

recurrence

Outcome Measures

Primary Outcomes (1)

  • Global survival

    36 months after intervention

Secondary Outcomes (1)

  • Disease free survival

    36 months after intervention

Study Arms (2)

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

Antibiotic lavagePROCEDURE

Peritoneal irrigation with gentamycin-clindamycin solution

Antibiotic lavage
Normal saline lavagePROCEDURE

Peritoneal irrigation with normal saline

Normal saline lavage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of colon neoplasms
  • plans to undergo an elective surgery with curative aims

You may not qualify if:

  • preoperative diagnosis of chronic renal failure (because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption)
  • allergy to gentamicin or clindamycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaime Ruiz-Tovar, MD, PhD

    Hospital Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03