Clinical trial NCT00451893: The Significance of the Mesh Thickness in the Operation of Inguinal Hernia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
polypropylene mesh
heavy-weight mesh
light-weight mesh
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Norrlandstingens Regionförbund
name: Jämtland County Council, Sweden
name: Västerbotten County Council, Sweden
First posted: 2007-03-26
Enrollment: 400
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male, age 25 years or older
* Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before

Exclusion Criteria:

* The patient is not able or do not want to give written informed consent
* The patient is not suitable for an operation in local anesthesia
* Anticoagulant medication or a known coagulation disorder

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Two, seven and eleven postoperative days. Four months and one year after the operation.
measure: Pain
timeFrame: Two, seven and eleven postoperative days. Four months and one year after the operation.
Secondary outcomes:
measure: Postoperative complications
timeFrame: Four months and one year after the operation.
measure: Recurrences
timeFrame: Four months and one year after the operation.
measure: Health-care costs
timeFrame: Four months and one year after the operation.
measure: Sick leave
timeFrame: Four months and one year after the operation.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Surgical and Perioperativ Sciences, Umeå University Hospital
city: Östersund
country: Sweden
facility: Östersund Hospital
Study officials:
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Markku M Haapamaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Erik Nilsson, MD, Ph D
role: STUDY_DIRECTOR
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Pär Nordin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Rojda Gumuscu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Martin Rutegård, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutegard M, Lindqvist M, Svensson J, Nordin P, Haapamaki MM. Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh. Br J Surg. 2021 Mar 12;108(2):138-144. doi: 10.1093/bjs/znaa049.
citation: Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, Haapamaki MM. Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh. Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20.