ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

This study is currently recruiting participants.

Verified by Malmö University Hospital, June 2007

First Received: May 10, 2007 Last Updated: June 8, 2007 History of Changes

Sponsors and Collaborators:	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
Information provided by:	Malmö 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

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Psychosocial, Longitudinal, Defined Population, Prospective Study
Official Title:	Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study.

Further study details as provided by Malmö University Hospital:

Estimated Enrollment:	170
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2008

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

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

Contacts

Contact: Peder Rogmark, MD	+46-40-331000	Peder.Rogmark@Skane.se
Contact: Agneta Montgomery, MD, PhD	+46-40-331000	Agneta.Montgomery@Skane.se

Locations

Sweden
Helsingborg Hospital, Department of Surgery	Recruiting
Helsingborg, Sweden, 251 87
Contact: Sam Smedberg, MD, PhD +46-42-100000
Principal Investigator: Sam Smedberg, MD, PhD
Arvika Hospital, Department of Surgery	Recruiting
Arvika, Sweden, SE-671 80
Contact: Emmanuel Ezra, MD +46-570-712000
Principal Investigator: Emmanuel Ezra, MD
Södertälje Hospital, Department of Surgery	Recruiting
Sodertalje, Sweden, SE-152 86
Contact: Sven Bringman, MD, PhD +46-8-550 240 00
Principal Investigator: Sven Bringman, MD, PhD
Malmö University Hospital, Department of Surgery	Recruiting
Malmö, Sweden, 20502
Contact: Peder Rogmark, MD +46-40-331000 Peder.Rogmark@Skane.se
Contact: Agneta Montgomery, MD, PhD +46-40-331000 Agneta.Montgomery@Skane.se
Principal Investigator: Peder Rogmark, MD
Principal Investigator: Agneta Montgomery, MD, PhD
Sub-Investigator: Ulf Petersson, MD, PhD
Mora Hospital, Department of Surgery	Recruiting
Mora, Sweden, SE-792 85
Contact: Johanna Österberg, MD, PhD +46-23-49 30 00
Principal Investigator: Johanna Österberg, MD, PhD
Sub-Investigator: Pernilla Olsson, MD
Lund University Hospital, Department of Surgery	Recruiting
Lund, Sweden, SE-222 41
Contact: Dan Sevonius, MD +46-46-17 10 00
Principal Investigator: Dan Sevonius, MD
Västerås Central Hospital, Department of Surgery	Recruiting
Vasteras, Sweden, SE-721 89
Contact: Arne Eklund, MD +46-21-17 30 00
Principal Investigator: Arne Eklund, MD

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Agneta Montgomery, MD, PhD

Malmo University Hospital, Lund University

More Information

No publications provided

Study ID Numbers:	LU030123PR, 200-06-005
Study First Received:	May 10, 2007
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00472537 History of Changes
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 Malmö University Hospital:

Ventral hernia
Incisional hernia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Ventral

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Ventral

ClinicalTrials.gov processed this record on May 06, 2009