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ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
This study is currently recruiting participants.
Study NCT00472537   Information provided by Malmö University Hospital
First Received: May 10, 2007   Last Updated: June 8, 2007   History of Changes

May 10, 2007
June 8, 2007
November 2005
 
 
 
Complete list of historical versions of study NCT00472537 on ClinicalTrials.gov Archive Site
 
 
 
ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study.

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.

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.

 
Observational
Psychosocial, Longitudinal, Defined Population, Prospective Study
Hernia, Ventral
  • Procedure: Retromuscular Mesh repair of midline incisional hernia
  • Procedure: Laparoscopic repair of midline incisional hernia
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
170
December 2008
 

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
Both
18 Years and older
No
Contact: Peder Rogmark, MD +46-40-331000 Peder.Rogmark@Skane.se
Contact: Agneta Montgomery, MD, PhD +46-40-331000 Agneta.Montgomery@Skane.se
Sweden
 
NCT00472537
 
LU030123PR, 200-06-005
Malmö University Hospital
  • Region Skåne FoUU
  • Lund University
  • Ethicon, Inc.
  • The Einar & Inga Nilsson Foundation, Malmö, Sweden
  • The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
  • Crafoord Foundation
Principal Investigator: Agneta Montgomery, MD, PhD Malmo University Hospital, Lund University
Malmö University Hospital
June 2007

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