Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure

Surgical Wound Infection Clinical Trial

Official title:

Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574702
• Other study ID #: ILEOS-ISS_2013
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: July 2018

Study information

• Verified date: April 2019
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• application of a contralateral drainage (Penrose ® device)
application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure

Locations

Country	Name	City	State
Spain	Hospital Universitario Parc Tauli de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application		30 days
Secondary	Number of patients with hematoma after ileostomy closure surgery		30 days
Secondary	Number of patients with seroma after ileostomy closure surgery		30 days
Secondary	Number of patients with anastomotic leak after ileostomy colsure surgery		30 days