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Completed

NCT Number: NCT00803985

Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain

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.

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Key information

Conditions

Chronic Pain Genital Diseases Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Urogenital Diseases

Age range

30 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Regionala etikprövningsnämden i Lund, avd 2

Lund, 221 00, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Extraperitoneal repair (TEP)

Procedure

Operation for primary inguinal hernias i men

Other names: Total extraperitoneal patch, Laparoscopic hernia operation, Hernia mesh operation

lichtenstein

Procedure

Operation for primary inguinal hernias i men

Other names: Open on lay mesh repair, Anterior mesh repair

Primary outcomes

  1. Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).

    Time frame: One year

    The worst pain last week one year postoperatively. Measured using question 2 of IPQ-questionaire with the cutoff for pain set between grade 2 (pain present but could easily be ignored) and grade 3 (pain present but does not interfere with everyday activities)

Secondary outcomes

  1. Quality of life measured using the SF-36 questionnaire

    Time frame: one and three years

    SF-36 is composed of eight sub-scales and the composite scores for physical and mental health. Norm-based scores were calculated using the Swedish age and gender specific means and standard deviations. The norm data have a mean of 50 and a standard deviation (SD) of 10. A 5-point difference corresponds to an effect size (Cohen's d) of 0.5 SD, which was regarded as a medium-sized clinical difference.

  2. Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire.

    Time frame: 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.

    Chronic pain was measured using IPQ with the following cutoffs. "Any pain last week" (IPQ2 grade 2-7) and "any pain right now" (IPQ2 grade 2-7) at 1 and 3 years. "Pain right now" (IPQ1 grade 3-7) at 1 and 3 years and "pain last week" (IPQ2 grade 3-7) at 3 years

  3. Clinical exam assessing groin complaints

    Time frame: Exams were performed preoperatively, at one and three years

    Clinical examination was performed assessing groin complaints were reported in six dimensions (no complaints, tenderness, decreased sensation to touch, decreased sensation to pricking, increased sensation to touch or pricking, radiation of pain) in five defined locations in the groin/scrotum area.

  4. A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia surgery.

    Time frame: Mean 33 months after surgery

    The first 2 questions adressing whether the patient is sexually active and if they have pain during intercourse. The following questions address pain-related sexual dysfunction by describing pain frequency, pain intensity, erectile or ejaculatory dysfunction and symptoms of depression.

    Two additional questions aimed to describe localisation and type of pain. Scores in the questionnaire vary between 0-12.

  5. Physical function score measuring the ability to perform common daily activities

    Time frame: The functional score was measured preoperatively, at one and three years

    Physical function was measured using a functional score that was created by assessing three daily activities. Climbing stairs, squatting and raising from bed Each activity was graded from 0-2 points (0 = no discomfort, 1 = mild/moderate discomfort, and 2 = severe discomfort in need of support) with a sum of all scores between 0-6.

  6. Number of patients with a recurrence after TEP and Lichtenstein surgery

    Time frame: After one and three years

    Recurrence after TEP and Lichtenstein repair.

  7. Number patients with a harmful event during surgery after TEP and Lichtenstein

    Time frame: After one and three years

    A harmful event was defined as an unplanned chronic inconvenient condition beyond therapy following surgery (e.g. testicular atrophy or pain that did not exist before operation).

  8. Number of patients with a adverse events after TEP and Lichtenstein surgery

    Time frame: After one and three years

    An adverse event was defined as either a reoperation due to a postoperative complication within 3 years or severe pain defined as IPQ2 grade 5-7

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Region Skane

Registry information

Official study 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

Acronym: TEP-LICH

Important dates

Study start
2008
Primary completion
2017
Study completion
2018
First posted
Dec 8, 2008
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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