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
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 157
Study Start Date: November 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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
Sampling Method:   Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Sweden
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, Malmö, Sweden
The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
Crafoord Foundation
Investigators
Principal Investigator: Agneta Montgomery, MD, PhD Malmo University Hospital, Lund University
  More Information

No publications provided

Responsible Party: Peder Rogmark, M.D.,, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00472537     History of Changes
Other Study ID Numbers: LU030123PR, 200-06-005
Study First Received: May 10, 2007
Last Updated: April 22, 2013
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 Skane University Hospital:
Ventral hernia
Incisional hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 20, 2014