Clinical trial NCT00803985: Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain
Official title: A Randomised Controlled Trial Comparing Total Extra-Peritoneal (TEP) to Lichtenstein Inguinal Hernia Repair Concerning Physical Sequelae and Quality of Life at One and Three Years - the TEPLICH Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Sexual Dysfunction
Keywords: Inguinal hernia
TEP
Lichtenstein
Mesh
Randomized
Chronic pain
Sexual dysfunction
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2008-12-08
Enrollment: 416
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery.

Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Detailed description: Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively.

Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.

Eligibility criteria: Inclusion Criteria:

* men between 30-75 years of age
* ASA class I-II
* primary unilateral inguinal hernia

Exclusion Criteria:

* lower midline incision below linea arcuate
* large scrotal hernia
* previously or current abuse,mental disease
* obesity BMI \> 35
* another simultaneous operation
* nonreducible hernia
* severe pain in the groin without nonrelated to hernia
* contraindications to general anesthesia
* need of language translator
* liver cirrhosis or ascites
* spread cancer disease
* previously irradiation in the area
* lack of operations indication

Primary outcomes:
measure: Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).
timeFrame: One year
Secondary outcomes:
measure: Quality of life measured using the SF-36 questionnaire
timeFrame: one and three years
measure: Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire.
timeFrame: IPQ1 grade 2-7, IPQ1 grade 3-7 and IPQ2 grade 2-7 measured at one and three years. IPQ2 grad 3-7 measured at three years.
measure: Clinical exam assessing groin complaints
timeFrame: Exams were performed preoperatively, at one and three years
measure: A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia surgery.
timeFrame: Mean 33 months after surgery
measure: Physical function score measuring the ability to perform common daily activities
timeFrame: The functional score was measured preoperatively, at one and three years
measure: Number of patients with a recurrence after TEP and Lichtenstein surgery
timeFrame: After one and three years
measure: Number patients with a harmful event during surgery after TEP and Lichtenstein
timeFrame: After one and three years
measure: Number of patients with a adverse events after TEP and Lichtenstein surgery
timeFrame: After one and three years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Regionala etikprövningsnämden i Lund, avd 2
Study officials:
affiliation: University of Lund
name: Agneta Montgomery, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutlic N, Gutlic A, Petersson U, Rogmark P, Montgomery A. Randomized clinical trial comparing total extraperitoneal with Lichtenstein inguinal hernia repair (TEPLICH trial). Br J Surg. 2019 Jun;106(7):845-855. doi: 10.1002/bjs.11230.