Post Operative PainNCT05863624
Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia
A study testing Open hernioplasty and TEP hernioplasty in people with Post Operative Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Open hernioplasty and TEP hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary inguinal hernia in females
Who cannot join
- emergency operation
- recurrent hernia
- groin pain without hernia
- frail and sick patient ASA ≥ 4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.
Read the detailed description
The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.
- Conditions
- Post Operative Pain
- Being tested
- Open hernioplasty, TEP hernioplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open hernioplastyProcedure or surgery
Also called Open Lichtenstein hernia repair
Inguinal hernia is operated using open surgery
TEP hernioplastyProcedure or surgery
Also called totally endoscopic hernia repair (TEP)
Inguinal hernia is operated using laparoendoscopic technique
| Study group | Role | What they receive |
|---|---|---|
| Open hernioplasty | Experimental | Open Lichtenstein hernia repair Receives: Procedure: Open hernioplasty |
| TEP hernioplasty | Active comparator | totally endoscopic hernia repair (TEP) Receives: Procedure: TEP hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery
Measured: from 1 week to one year
Secondary outcomes (4)
Complications
Postoperative complications of surgery (wound infection, hemorrhage)
Measured: 1 month
Recurrence
Hernia recurrences after 5 years
Measured: 5 years
Sick leave
how many days the patient is not working after surgery
Measured: 0-30 days
Treatment costs
how much in euros the surgical treatment will cost
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Model description
- Randomized follow-up study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, North Karelia Central Hospital, Jyväskylä Central Hospital, Mikkeli Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863624
- Sponsor's protocol ID
- KUH5200667
- Status last verified
- May 2023
- First submitted
- 17 Apr 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
- ClinicalTrials.gov ID
- NCT05863624
- Acronym / sponsor ID
- KUH5200667
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, North Karelia Central Hospital, Jyväskylä Central Hospital, Mikkeli Central Hospital
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2023 (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.
This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.
Detailed description
The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized follow-up study
| Arm | Type | Receives |
|---|---|---|
| Open hernioplasty | Experimental | Procedure: Open hernioplastyOpen Lichtenstein hernia repair |
| TEP hernioplasty | Active comparator | Procedure: TEP hernioplastytotally endoscopic hernia repair (TEP) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary inguinal hernia in females
Key exclusion criteria (4 listed)
- emergency operation
- recurrent hernia
- groin pain without hernia
- frail and sick patient ASA ≥ 4
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 |
|---|---|---|
| Open hernioplastyAlso: Open Lichtenstein hernia repairInguinal hernia is operated using open surgery | Procedure or surgery | Open hernioplasty |
| TEP hernioplastyAlso: totally endoscopic hernia repair (TEP)Inguinal hernia is operated using laparoendoscopic technique | Procedure or surgery | TEP hernioplasty |
Primary outcome
Chronic pain
Time frame: from 1 week to one year
Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery
4 secondary outcomes
Complications
Time frame: 1 month
Recurrence
Time frame: 5 years
Sick leave
Time frame: 0-30 days
Treatment costs
Time frame: 0-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open hernioplasty and TEP hernioplasty in people with Post Operative Pain, 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 4 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: opening soon, as of the sponsor's last update on 6 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannu EK Paajanen, MD (0405263101 ext. +358, paajanen@surffi.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain (time frame: from 1 week to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.