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

Corporacion Parc Tauli

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Procedure: application of a contralateral drainage (Penrose ® device)

Study type: Interventional

Funder types: Other

Identifiers

NCT02574702

ILEOS-ISS_2013

Details and patient eligibility

About

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

Full 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

Enrollment: 78 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients with primary loop ileostomy closure without drainage of the surgical wound

Drainage Group

Experimental group

Description:

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.

Treatment:

Procedure: application of a contralateral drainage (Penrose ® device)