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NCT Number: NCT02574702

Trial to Reduce Wound Infection With Contralateral Drainage 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

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, 08208, Spain

About this study

  • 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.

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

application of a contralateral drainage (Penrose ® device)

Procedure

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

Primary outcomes

  1. Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application

    Time frame: 30 days

Secondary outcomes

  1. Number of patients with hematoma after ileostomy closure surgery

    Time frame: 30 days

  2. Number of patients with seroma after ileostomy closure surgery

    Time frame: 30 days

  3. Number of patients with anastomotic leak after ileostomy colsure surgery

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Oct 14, 2015
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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