Status:
COMPLETED
ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
Lead Sponsor:
Skane University Hospital
Collaborating Sponsors:
Region Skåne FoUU
Lund University
Conditions:
HERNIA, VENTRAL
Eligibility:
All Genders
18+ years
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 pos...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00472537
Start Date
November 1 2005
End Date
November 1 2010
Last Update
April 24 2013
Active Locations (7)
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1
Malmö University Hospital, Department of Surgery
Malmo, Malmö, Sweden, 20502
2
Arvika Hospital, Department of Surgery
Arvika, Sweden, SE-671 80
3
Helsingborg Hospital, Department of Surgery
Helsingborg, Sweden, 251 87
4
Lund University Hospital, Department of Surgery
Lund, Sweden, SE-222 41