Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not? - Full Text View

Sponsored by:	University of Lausanne Hospitals
Information provided by:	University of Lausanne Hospitals
ClinicalTrials.gov Identifier:	NCT00478348

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 Device: Insertion of 3 drains (Redon)

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.

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 ]

Estimated Enrollment:	380
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2007

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

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

Contacts

Contact: Alexandre Paroz, MD	+41 21 314 52 34	alexandre.paroz@chuv.ch
Contact: Henri Vuilleumier, MD	+41 21 314 23 50	henri.vuilleumier@chuv.ch

Locations

Switzerland, Vaud
Department of Visceral Surgery, University Hospital Center	Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Alexandre Paroz, MD +41 21 314 52 34 alexandre.paroz@chuv.ch
Contact: Henri Vuilleumier, MD +41 21 314 23 50 henri.vuilleumier@chuv.ch
Principal Investigator: Alexandre Paroz, MD
Sub-Investigator: Henri Vuilleumier, MD
Sub-Investigator: Anna Dayer, 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

Study ID Numbers:	DP-2007-CHV-UNIL
Study First Received:	May 22, 2007
Last Updated:	May 22, 2007
ClinicalTrials.gov Identifier:	NCT00478348 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:

Postoperative Complications
Drainage
Infection
Seroma
Hematoma

Recurrence
Abdominal Wall
Hernia
Surgical Mesh

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hematoma
Postoperative Complications
Hernia

Hernia, Abdominal
Seroma
Recurrence

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Pathologic Processes
Postoperative Complications
Hernia
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 07, 2009