ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Peder Rogmark, Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00472537
First received: May 10, 2007
Last updated: April 22, 2013
Last verified: April 2013

May 10, 2007
April 22, 2013
November 2005
November 2010   (final data collection date for primary outcome measure)
Postoperative pain recorded in SF-36 [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: No ]
Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain
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Complete list of historical versions of study NCT00472537 on ClinicalTrials.gov Archive Site
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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
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients referred to specialist centers for treatment of midline incisional hernias.

HERNIA, VENTRAL
  • Procedure: Retromuscular Mesh repair of midline incisional hernia
  • Procedure: Laparoscopic repair of midline incisional hernia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
November 2010
November 2010   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
Sweden
 
NCT00472537
LU030123PR, 200-06-005
No
Peder Rogmark, Skane University Hospital
Skane 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
Skane University Hospital
April 2013

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