Chronic PainTEP-LICHNCT00803985
Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain
A study testing Total Extraperitoneal repair (TEP) and Lichtenstein in people with Chronic Pain and Sexual Dysfunction, run by Skane University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Chronic Pain, Sexual Dysfunction
- What is being tested?
- Total Extraperitoneal repair (TEP) and Lichtenstein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men between 30-75 years of age
- ASA class I-II
- primary unilateral inguinal hernia
Who cannot join
- lower midline incision below linea arcuate
- large scrotal hernia
- previously or current abuse,mental disease
- obesity BMI > 35
- another simultaneous operation
- nonreducible hernia
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain, Sexual Dysfunction
- Being tested
- Total Extraperitoneal repair (TEP), Lichtenstein
- Keywords
- Inguinal hernia, TEP, Lichtenstein, Mesh, Randomized, Chronic pain, Sexual dysfunction
- Medical subject headings
- Chronic Pain, Sexual Dysfunction, Physiological, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Extraperitoneal repair (TEP)Procedure or surgery
Also called Total extraperitoneal patch, Laparoscopic hernia operation, Hernia mesh operation
Operation for primary inguinal hernias i men
LichtensteinProcedure or surgery
Also called Open on lay mesh repair, Anterior mesh repair
Operation for primary inguinal hernias i men
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein | Active comparator | Open operation with onlay light weight polypropylene mesh Receives: Procedure: Total Extraperitoneal repair (TEP) |
| Total Extraperitoneal repair (TEP) | Active comparator | Laparoscopic operation with preperitoneal nonfixated mesh Receives: Procedure: Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).
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)
Measured: One year
Secondary outcomes (8)
Quality of life measured using the SF-36 questionnaire
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.
Measured: one and three years
Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire.
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
Measured: 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.
Clinical exam assessing groin complaints
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.
Measured: Exams were performed preoperatively, at one and three years
A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia 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.
Measured: Mean 33 months after surgery
Physical function score measuring the ability to perform common daily activities
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.
Measured: The functional score was measured preoperatively, at one and three years
Number of patients with a recurrence after TEP and Lichtenstein surgery
Recurrence after TEP and Lichtenstein repair.
Measured: After one and three years
Number patients with a harmful event during surgery after TEP and Lichtenstein
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).
Measured: After one and three years
Number of patients with a adverse events after TEP and Lichtenstein surgery
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
Measured: After one and three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Agneta Montgomery, Skane University Hospital
- Investigators
- Agneta Montgomery, MD, PhD, Principal investigator, University of Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803985
- Sponsor's protocol ID
- 596/2007
- Acronym
- TEP-LICH
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2008
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31162663
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00803985
- Acronym / sponsor ID
- TEP-LICH / 596/2007
- Conditions
- Chronic Pain, Sexual Dysfunction
- Keywords
- Inguinal hernia, TEP, Lichtenstein, Mesh, Randomized, Chronic pain, Sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Apr 2008 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein | Active comparator | Procedure: Total Extraperitoneal repair (TEP)Open operation with onlay light weight polypropylene mesh |
| Total Extraperitoneal repair (TEP) | Active comparator | Procedure: LichtensteinLaparoscopic operation with preperitoneal nonfixated mesh |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men between 30-75 years of age
- ASA class I-II
- primary unilateral inguinal hernia
Key exclusion criteria (13 listed)
- lower midline incision below linea arcuate
- large scrotal hernia
- previously or current abuse,mental disease
- obesity BMI > 35
- another simultaneous operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Extraperitoneal repair (TEP)Also: Total extraperitoneal patch, Laparoscopic hernia operation, Hernia mesh operationOperation for primary inguinal hernias i men | Procedure or surgery | Lichtenstein |
| LichtensteinAlso: Open on lay mesh repair, Anterior mesh repairOperation for primary inguinal hernias i men | Procedure or surgery | Total Extraperitoneal repair (TEP) |
Primary outcome
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)
8 secondary outcomes
Quality of life measured using the SF-36 questionnaire
Time frame: one and three years
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.
Clinical exam assessing groin complaints
Time frame: Exams were performed preoperatively, at one and three years
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
Physical function score measuring the ability to perform common daily activities
Time frame: The functional score was measured preoperatively, at one and three years
Number of patients with a recurrence after TEP and Lichtenstein surgery
Time frame: After one and three years
Number patients with a harmful event during surgery after TEP and Lichtenstein
Time frame: After one and three years
Number of patients with a adverse events after TEP and Lichtenstein surgery
Time frame: After one and three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Derived from this study: PubMed 31162663Gutlic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agneta Montgomery, MD, PhD principal investigator
University of Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Extraperitoneal repair (TEP) and Lichtenstein in people with Chronic Pain and Sexual Dysfunction, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ). (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.