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

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.
 
ClinicalTrials.gov Identifier: NCT00478348
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE May 22, 2007
First Posted Date  ICMJE May 24, 2007
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE May 2007
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2007)
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings. [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00478348 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
Official Title  ICMJE Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Complications
  • Hernia
Intervention  ICMJE Procedure: Prosthetic repair of abdominal incisional hernia
Rives-Stoppa repair of incisional hernia
Study Arms  ICMJE
  • Drain
    Intervention: Procedure: Prosthetic repair of abdominal incisional hernia
  • No drain
    Intervention: Procedure: Prosthetic repair of abdominal incisional hernia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2007)
380
Actual Study Completion Date  ICMJE November 10, 2017
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00478348
Other Study ID Numbers  ICMJE DP-2007-CHV-UNIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicolas DEMARTINES, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
PRS Account University of Lausanne Hospitals
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP