NCT00472537

ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HERNIA, VENTRAL

Interventions

Type	Name	Description
PROCEDURE	Retromuscular Mesh repair of midline incisional hernia
PROCEDURE	Laparoscopic repair of midline incisional hernia

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-05-11
• Last updated: 2013-04-24

Locations

7 sites across 1 country: Sweden