The Significance of the Mesh Thickness in the Operation of Inguinal Hernia (LJUNO)
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|ClinicalTrials.gov Identifier: NCT00451893|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2007
Last Update Posted : June 1, 2016
The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.
Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Procedure: Lichtenstein operation with a heavy-weight mesh Procedure: Lichtenstein operation with a light-weight mesh||Phase 2 Phase 3|
The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.
In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||November 2016|
Active Comparator: Heavy-weight
Lichtenstein operation performed with a heavy-weight mesh.
Procedure: Lichtenstein operation with a heavy-weight mesh
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Active Comparator: Light-weight
Lichtenstein operation performed with a light-weight mesh.
Procedure: Lichtenstein operation with a light-weight mesh
Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
- Health-related Quality of Life [ Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation. ]
- Pain [ Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation. ]
- Postoperative complications [ Time Frame: Four months and one year after the operation. ]
- Recurrences [ Time Frame: Four months and one year after the operation. ]
- Health-care costs [ Time Frame: Four months and one year after the operation. ]
- Sick leave [ Time Frame: Four months and one year after the operation. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451893
|Department of Surgical and Perioperativ Sciences, Umeå University Hospital|
|Umeå, Sweden, SE 90185|
|Östersund, Sweden, SE 83183|
|Principal Investigator:||Markku M Haapamaki, MD, PhD||Umeå University, Department of Surgical and Perioperative Sciences|
|Study Director:||Erik Nilsson, MD, Ph D||Umeå University, Department of Surgical and Perioperative Sciences|
|Principal Investigator:||Pär Nordin, MD, PhD||Umeå University, Department of Surgical and Perioperative Sciences|
|Principal Investigator:||Rojda Gumuscu, MD||Umeå University, Department of Surgical and Perioperative Sciences|
|Principal Investigator:||Martin Rutegård, MD, PhD||Umeå University, Department of Surgical and Perioperative Sciences|