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Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Nicolas DEMARTINES, University of Lausanne Hospitals.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478348
First Posted: May 24, 2007
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
  Purpose
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.

Condition Intervention
Postoperative Complications Hernia Procedure: Prosthetic repair of abdominal incisional hernia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Nicolas DEMARTINES, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings. [ Time Frame: 30 days ]

Estimated Enrollment: 380
Study Start Date: May 2007
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drain Procedure: Prosthetic repair of abdominal incisional hernia
Rives-Stoppa repair of incisional hernia
No drain Procedure: Prosthetic repair of abdominal incisional hernia
Rives-Stoppa repair of incisional hernia

Detailed Description:

Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.

Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.

Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.

In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.

The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of midline abdominal wall incisional hernia
  • Adults of 20 to 80 years old
  • ASA I to III
  • Inform consent signed by the patient and investigators

Exclusion Criteria:

  • Incisional hernia less than 2 cm
  • Groin hernia
  • Antibiotic treatment before and during hospital admission
  • Emergency admission for strangulated incisional hernia
  • Immunosuppressing treatment
  Contacts and Locations
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): NCT00478348


Contacts
Contact: Pierre Allemann, MD +41 795561481 pierre.allemann@chuv.ch
Contact: Anna Dayer-Jankechova, MD Anna.Dayer-Jankechova@chuv.ch

Locations
Switzerland
Department of Visceral Surgery, University Hospital Center Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Pierre Allemann, MD    +41795561481    pierre.allemann@chuv.ch   
Contact: Anna Dayer-Jankechova, MD       anna.dayer-jankechova@chuv.ch   
Principal Investigator: Pierre Allemann, MD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
  More Information

Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00478348     History of Changes
Other Study ID Numbers: DP-2007-CHV-UNIL
First Submitted: May 22, 2007
First Posted: May 24, 2007
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
Postoperative Complications
Drainage
Infection
Seroma
Hematoma
Recurrence
Abdominal Wall
Hernia
Surgical Mesh

Additional relevant MeSH terms:
Hernia
Postoperative Complications
Hernia, Abdominal
Incisional Hernia
Pathological Conditions, Anatomical
Pathologic Processes