ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment (ProLOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472537
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : April 24, 2013
Region Skåne FoUU
Lund University
Ethicon, Inc.
The Einar & Inga Nilsson Foundation
The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
Crafoord Foundation
Information provided by (Responsible Party):
Peder Rogmark, Skane University Hospital

Brief Summary:
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 or disease Intervention/treatment
HERNIA, VENTRAL Procedure: Retromuscular Mesh repair of midline incisional hernia Procedure: Laparoscopic repair of midline incisional hernia

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.

Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study
Study Start Date : November 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Primary Outcome Measures :
  1. Postoperative pain recorded in SF-36 [ Time Frame: 3 weeks after surgery ]
    Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred to specialist centers for treatment of midline incisional hernias.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472537

Arvika Hospital, Department of Surgery
Arvika, Sweden, SE-671 80
Helsingborg Hospital, Department of Surgery
Helsingborg, Sweden, 251 87
Lund University Hospital, Department of Surgery
Lund, Sweden, SE-222 41
Malmö University Hospital, Department of Surgery
Malmö, Sweden, 20502
Mora Hospital, Department of Surgery
Mora, Sweden, SE-792 85
Södertälje Hospital, Department of Surgery
Sodertalje, Sweden, SE-152 86
Västerås Central Hospital, Department of Surgery
Vasteras, Sweden, SE-721 89
Sponsors and Collaborators
Skane University Hospital
Region Skåne FoUU
Lund University
Ethicon, Inc.
The Einar & Inga Nilsson Foundation
The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
Crafoord Foundation
Principal Investigator: Agneta Montgomery, MD, PhD Malmo University Hospital, Lund University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peder Rogmark, M.D.,, Skane University Hospital Identifier: NCT00472537     History of Changes
Other Study ID Numbers: LU030123PR
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Peder Rogmark, Skane University Hospital:
Ventral hernia
Incisional hernia

Additional relevant MeSH terms:
Incisional Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Hernia, Abdominal