Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
1 other identifier
interventional
78
1 country
1
Brief Summary
- 1.Introduction:
- 2.Objectives and Hypothesis:
- 3.Methodology:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 18, 2019
April 1, 2019
3.3 years
March 18, 2013
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
30 days
Secondary Outcomes (3)
Number of patients with hematoma after ileostomy closure surgery
30 days
Number of patients with seroma after ileostomy closure surgery
30 days
Number of patients with anastomotic leak after ileostomy colsure surgery
30 days
Study Arms (2)
Control Group
NO INTERVENTIONPatients with primary loop ileostomy closure without drainage of the surgical wound
Drainage Group
EXPERIMENTALPatients with the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure. Intervention: application of a contralateral drainage in surgical wound closure.
Interventions
application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure
Eligibility Criteria
You may qualify if:
- Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
- Over 18 years.
- Surgery scheduled.
- Informed consent signed.
You may not qualify if:
- Patients with terminal ileostomy.
- Patients with loop ileostomy different from any surgery of rectal cancer.
- To require another surgical procedure added.
- Urgent surgery.
- Patient refusal to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Parc Tauli de Sabadell
Sabadell, Barcelona, 08208, Spain
Related Publications (1)
Serracant A, Serra-Aracil X, Mora-Lopez L, Pallisera-Lloveras A, Serra-Pla S, Zarate-Pinedo A, Navarro-Soto S. The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1692-1699. doi: 10.1007/s00268-019-04972-6.
PMID: 30824960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Serra-Aracil, MD
Hospital Universitario Parc Tauli de Sabadell
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
March 18, 2013
First Posted
October 14, 2015
Study Start
February 1, 2013
Primary Completion
June 1, 2016
Study Completion
July 1, 2018
Last Updated
April 18, 2019
Record last verified: 2019-04