ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

Completed

• Conditions: HERNIA, VENTRAL

• Registration Number: NCT00472537
• Lead Sponsor: Skane University Hospital

Brief 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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain recorded in SF-36	3 weeks after surgery	Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain

Trial Locations

Locations (7)

Lund University Hospital, Department of Surgery; 🇸🇪 Lund, Sweden

Malmö University Hospital, Department of Surgery; 🇸🇪 Malmö, Sweden

Helsingborg Hospital, Department of Surgery; 🇸🇪 Helsingborg, Sweden

Västerås Central Hospital, Department of Surgery; 🇸🇪 Vasteras, Sweden

Södertälje Hospital, Department of Surgery; 🇸🇪 Sodertalje, Sweden

Arvika Hospital, Department of Surgery; 🇸🇪 Arvika, Sweden

Mora Hospital, Department of Surgery; 🇸🇪 Mora, Sweden