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

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ClinicalTrials.gov Identifier: NCT02574702
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli

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


Condition or disease Intervention/treatment Phase
Surgical Wound Infection Procedure: application of a contralateral drainage (Penrose ® device) Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
Actual Study Start Date : February 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574702


Locations
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Spain
Hospital Universitario Parc Tauli de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Xavier Serra-Aracil, MD Hospital Universitario Parc Tauli de Sabadell

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xavier Serra-Aracil, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02574702     History of Changes
Other Study ID Numbers: ILEOS-ISS_2013
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Keywords provided by Xavier Serra-Aracil, Corporacion Parc Tauli:
superficial surgical site infection
loop ileostomy
Ileostomy closure

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries