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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Lausanne Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00478348
First received: May 22, 2007
Last updated: April 21, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 380
Study Start Date: May 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478348

Contacts
Contact: Andrea Donadini, MD +41 795561481 andrea.donadini@chuv.ch
Contact: Henri Vuilleumier, MD +41 21 314 23 50 henri.vuilleumier@chuv.ch

Locations
Switzerland
Department of Visceral Surgery, University Hospital Center Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Andrea Donadini, MD    +41795561481    andrea.donadini@chuv.ch   
Contact: Henri Vuilleumier, MD    +41 21 314 23 50    henri.vuilleumier@chuv.ch   
Principal Investigator: Andrea Donadini, MD         
Sub-Investigator: Henri Vuilleumier, 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

No publications provided

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
Study First Received: May 22, 2007
Last Updated: April 21, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014