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ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

This study is currently recruiting participants.
Verified by Malmö University Hospital, June 2007

Sponsors and Collaborators: Malmö University Hospital
Region Skåne FoUU
Lund University Hospital
Ethicon, Inc.
The Einar & Inga Nilsson Foundation, Malmö, Sweden
The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
The Crafoord Foundation, Lund, Sweden
Information provided by: Malmö University Hospital
ClinicalTrials.gov Identifier: NCT00472537
  Purpose

This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.


Condition Intervention
Hernia, Ventral
Procedure: Retromuscular Mesh repair of midline incisional hernia
Procedure: Laparoscopic repair of midline incisional hernia

MedlinePlus related topics:   Hernia   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Psychosocial, Longitudinal, Defined Population, Prospective Study
Official Title:   Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study.

Further study details as provided by Malmö University Hospital:

Estimated Enrollment:   170
Study Start Date:   November 2005
Estimated Study Completion Date:   December 2008

Detailed Description:

Incisional ventral hernia after abdominal surgery is a fairly common condition. In recent years the use of a prosthesis in the repair procedure has proved very effective in preventing a new hernia. A retromuscular mesh placement seems to have superior results. The mesh may be placed retromuscular through an open surgical procedure or through a laparoscopic procedure in an intra-abdominal position. Both procedures are highly standardized. A heavy weight mesh is used in the open procedure, fixed in the midline only, and a composite mesh is used intraabdominally and fixed only with titanium tackers.

SF-36 is used to assess the quality of life, and its subscale BP (bodily pain) is used as primary outcome 3 weeks postoperatively. Secondary endpoints are return to daily life, pain, complications, recurrence, patient satisfaction and cosmetic outcome.

Subjects are assessed at 1,3,8 weeks post operation and after 12 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age over 18 years
  • Postoperative hernias in the region of the recti abdomini muscles with a defect of less than 10 cm transversal width
  • No contraindications to laparoscopic procedure
  • The patient should be able to adequate ventilation/respiration after reduction of hernia contents
  • Indications for elective surgery

Exclusion Criteria:

  • Pregnant women
  • Prior operation of abdominal hernia with mesh placement in the compartment of the rectus abdominus muscle (i.e. prior onlay mesh is acceptable)
  • Need of an interpreter
  • Current drug abuse, mental disorder or other condition which makes the patient incapable of postoperative follow up
  • Body Mass index (BMI) >40
  • Other planned concurrent operation
  • Current oral steroid treatment, or other immune system modulating treatment
  • Incarcerated incisional hernias
  • Parastomal hernias
  • Prior history of open abdomen
  • Enterocutaneous fistula or cutaneous infection
  • Hepatic cirrhosis or ascites
  • Generalized malignancy
  • History of radiation treatment in the abdomen.
  • ASA >III
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472537

Contacts
Contact: Peder Rogmark, MD     +46-40-331000     Peder.Rogmark@Skane.se    
Contact: Agneta Montgomery, MD, PhD     +46-40-331000     Agneta.Montgomery@Skane.se    

Locations
Sweden
Helsingborg Hospital, Department of Surgery     Recruiting
      Helsingborg, Sweden, 251 87
      Contact: Sam Smedberg, MD, PhD     +46-42-100000        
      Principal Investigator: Sam Smedberg, MD, PhD            
Arvika Hospital, Department of Surgery     Recruiting
      Arvika, Sweden, SE-671 80
      Contact: Emmanuel Ezra, MD     +46-570-712000        
      Principal Investigator: Emmanuel Ezra, MD            
Södertälje Hospital, Department of Surgery     Recruiting
      Sodertalje, Sweden, SE-152 86
      Contact: Sven Bringman, MD, PhD     +46-8-550 240 00        
      Principal Investigator: Sven Bringman, MD, PhD            
Malmö University Hospital, Department of Surgery     Recruiting
      Malmö, Sweden, 20502
      Contact: Peder Rogmark, MD     +46-40-331000     Peder.Rogmark@Skane.se    
      Contact: Agneta Montgomery, MD, PhD     +46-40-331000     Agneta.Montgomery@Skane.se    
      Principal Investigator: Peder Rogmark, MD            
      Principal Investigator: Agneta Montgomery, MD, PhD            
      Sub-Investigator: Ulf Petersson, MD, PhD            
Mora Hospital, Department of Surgery     Recruiting
      Mora, Sweden, SE-792 85
      Contact: Johanna Österberg, MD, PhD     +46-23-49 30 00        
      Principal Investigator: Johanna Österberg, MD, PhD            
      Sub-Investigator: Pernilla Olsson, MD            
Lund University Hospital, Department of Surgery     Recruiting
      Lund, Sweden, SE-222 41
      Contact: Dan Sevonius, MD     +46-46-17 10 00        
      Principal Investigator: Dan Sevonius, MD            
Västerås Central Hospital, Department of Surgery     Recruiting
      Vasteras, Sweden, SE-721 89
      Contact: Arne Eklund, MD     +46-21-17 30 00        
      Principal Investigator: Arne Eklund, MD            

Sponsors and Collaborators
Malmö University Hospital
Region Skåne FoUU
Lund University Hospital
Ethicon, Inc.
The Einar & Inga Nilsson Foundation, Malmö, Sweden
The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
The Crafoord Foundation, Lund, Sweden

Investigators
Principal Investigator:     Agneta Montgomery, MD, PhD     Malmo University Hospital, Lund University    
  More Information


Study ID Numbers:   LU030123PR, 200-06-005
First Received:   May 10, 2007
Last Updated:   June 8, 2007
ClinicalTrials.gov Identifier:   NCT00472537
Health Authority:   Sweden: Regional Ethical Review Board;   Sweden: Swedish National Council on Medical Ethics;   Sweden: The National Board of Health and Welfare

Keywords provided by Malmö University Hospital:
Ventral hernia  
Incisional hernia  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Ventral

ClinicalTrials.gov processed this record on October 10, 2008




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