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

NCT ID: NCT02574702

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-07-31

Brief 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

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

Conditions

Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

application of a contralateral drainage (Penrose ® device)

Intervention Type: PROCEDURE

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

Interventions

application of a contralateral drainage (Penrose ® device)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Xavier Serra-Aracil

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xavier Serra-Aracil, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Parc Tauli de Sabadell

Locations

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30824960 (View on PubMed)

Other Identifiers

ILEOS-ISS_2013

Identifier Type: -

Identifier Source: org_study_id