Inguinal HerniaNCT03566433
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
A study testing Tep surgery for inguinal hernia and Lichtenstein in people with Inguinal Hernia and Hernia, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Hernia
- What is being tested?
- Tep surgery for inguinal hernia and Lichtenstein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2017to 31 May 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Who cannot join
- Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.
Read the detailed description
Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.
- Conditions
- Inguinal Hernia, Hernia
- Being tested
- Tep surgery for inguinal hernia, Lichtenstein
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tep surgery for inguinal herniaProcedure or surgery
TEP surgery
LichtensteinProcedure or surgery
Lichtenstein surgery for inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic TEP surgery | Active comparator | Routine total extraperitoneal technique surgery for inguinal hernia Receives: Procedure: Tep surgery for inguinal hernia |
| Open Lichtenstein hernioplasty | Active comparator | Routine lichtenstein surgery for inguinal hernia Receives: Procedure: Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores (0-100) after surgery
Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome
Measured: from day 1 to 1 month postoperatively
Secondary outcomes (2)
Number of operative complications
Any minor or major complication
Measured: from day 1 to 1 month postoperatively
Number of re-operations
Any re-operation
Measured: 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 May 2020
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 Inguinal HerniaStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, North Karelia Central Hospital, Mikkeli Central Hospital, Päijänne Tavastia Central Hospital
- Responsible party
- Sponsor
- Investigators
- Hannu Paajanen, Prof, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566433
- Sponsor's protocol ID
- KuopioUH
- Status last verified
- Oct 2021
- First submitted
- 12 Jun 2018
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.
PubMed 34791044
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
- ClinicalTrials.gov ID
- NCT03566433
- Acronym / sponsor ID
- KuopioUH
- Conditions
- Inguinal Hernia, Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, North Karelia Central Hospital, Mikkeli Central Hospital, Päijänne Tavastia Central Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 25 Jun 2018 (actual)
- 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.
Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.
Detailed description
Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic TEP surgery | Active comparator | Procedure: Tep surgery for inguinal herniaRoutine total extraperitoneal technique surgery for inguinal hernia |
| Open Lichtenstein hernioplasty | Active comparator | Procedure: LichtensteinRoutine lichtenstein surgery for inguinal hernia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Key exclusion criteria (1 listed)
- Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
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 |
|---|---|---|
| Tep surgery for inguinal herniaTEP surgery | Procedure or surgery | Endoscopic TEP surgery |
| LichtensteinLichtenstein surgery for inguinal hernia | Procedure or surgery | Open Lichtenstein hernioplasty |
Primary outcome
Pain scores (0-100) after surgery
Time frame: from day 1 to 1 month postoperatively
Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome
2 secondary outcomes
Number of operative complications
Time frame: from day 1 to 1 month postoperatively
Number of re-operations
Time frame: 1 month after the operation
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 1 Nov 2021.
- Derived from this study: PubMed 34791044Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Hannu Paajanen, Prof study director
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tep surgery for inguinal hernia and Lichtenstein in people with Inguinal Hernia and Hernia, run by Kuopio University Hospital at 1 site in Finland.
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 1 inclusion and 1 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 1 Nov 2021. 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 Finland. 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?
Pain scores (0-100) after surgery (time frame: from day 1 to 1 month postoperatively). 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 NCT03566433, 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 1 Nov 2021.