ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

This study is ongoing, but not recruiting participants.

First Received on May 10, 2007. Last Updated on September 2, 2010 History of Changes

Sponsor:	Skane University Hospital
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:	Skane 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

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:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Skane University Hospital:

Estimated Enrollment:	170
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2010
Primary Completion Date:	November 2009 (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

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:	Dr Agneta Montgomery, PHD, Lund University, Malmö 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:	September 2, 2010
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 February 12, 2012