ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
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.
Procedure: Retromuscular Mesh repair of midline incisional hernia
Procedure: Laparoscopic repair of midline incisional hernia
|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|
- 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
|Study Start Date:||November 2005|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Agneta Montgomery, MD, PhD||Malmo University Hospital, Lund University|