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. Introduction:

   The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure.

2. Objectives and Hypothesis:

   Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.

   Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.

3. Methodology:

Prospective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate. Monitorization until 30 days after surgery

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Procedure: application of a contralateral drainage (Penrose ® device)

Detailed Description

1. Introduction:

   The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). In the literature there are various techniques related to closing loop ileostomy that try to reduce the rate of infections recorded. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure.

2. Objectives and Hypothesis:

   Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.

   Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.

   Secondary objectives:

   • Identify risk factors associated with superficial surgical site infection in relation to a primary loop ileostomy closure (with or without drainage).
   • Reducing hospital stay and care at home.
3. Methodology:

Prospective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate.

It will be used a simple randomization. To assess the occurrence of superficial incisional infection, the investigators will be monitoring patients till 30 days after surgery

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitario Parc Tauli de Sabadell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
• Over 18 years.
• Surgery scheduled.
• Informed consent signed.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients with primary loop ileostomy closure without drainage of the surgical wound
Experimental: Drainage Group; Patients 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.	Procedure: application of a contralateral drainage (Penrose ® device); application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Xavier Serra-Aracil, MD, Hospital Universitario Parc Tauli de Sabadell

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: October 12, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: loop ileostomy; superficial surgical site infection; Ileostomy closure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: ILEOS-ISS_2013