Pain, PostoperativeNCT03734224
Inguinal Hernia Operation and Postoperative Pain
A study testing Adhesix mesh and Progrip mesh in people with Pain, Postoperative and Inguinal Hernia, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Pain, Postoperative, Inguinal Hernia, Quality of Life
- What is being tested?
- Adhesix mesh and Progrip mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2018to 1 Apr 2022
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.
Who cannot join
- female
- bilateral hernia
- Incarcerated hernia
- Scrotal hernia
- ASA-classification >3
- BMI >35 or <18
Show all 10Show fewer
- No hernia found in clinical examination
- Liver cirrhosis
- Other contraindication for inguinal hernia operation
- Anticoagulant therapy, that needs bridge therapy when paused
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study
Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.
- Conditions
- Pain, Postoperative, Inguinal Hernia, Quality of Life
- Being tested
- Adhesix mesh, Progrip mesh
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesix meshProcedure or surgery
Adhesix mesh
Progrip meshProcedure or surgery
Progrip mesh
| Study group | Role | What they receive |
|---|---|---|
| Group1: Adhesix | Active comparator | This group gets the Adhesix mesh in a normal open hernia operation. Receives: Procedure: Adhesix mesh |
| Group 2: Progrip | Active comparator | This group gets the Progrip mesh in a normal open hernia operation. Receives: Procedure: Progrip mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contacts due to postoperative pain
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation
Measured: 3 months
Secondary outcomes (3)
The use of pain medication
The use of painkillers postoperatively
Measured: 1 year
Pain intensity
The pain intensity at the Numeric Pain Rating Scale (NPRS), where the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine")
Measured: 1 year
Number of contacts
Number of contacts to the operating unit/health care system due to pain after the operation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 Pain, PostoperativeStudies 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna-Maria Thölix, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734224
- Sponsor's protocol ID
- HUS-459-2018-61
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2018
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tholix AM, Kossi J, Harju J. One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial. Langenbecks Arch Surg. 2023 Sep 21;408(1):369. doi: 10.1007/s00423-023-03106-w.
PubMed 37733083
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT03734224
- Acronym / sponsor ID
- HUS-459-2018-61
- Conditions
- Pain, Postoperative, Inguinal Hernia, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 7 Nov 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.
Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Adhesix | Active comparator | Procedure: Adhesix meshThis group gets the Adhesix mesh in a normal open hernia operation. |
| Group 2: Progrip | Active comparator | Procedure: Progrip meshThis group gets the Progrip mesh in a normal open hernia operation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.
Key exclusion criteria (10 listed)
- female
- bilateral hernia
- Incarcerated hernia
- Scrotal hernia
- ASA-classification >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 |
|---|---|---|
| Adhesix meshAdhesix mesh | Procedure or surgery | Group1: Adhesix |
| Progrip meshProgrip mesh | Procedure or surgery | Group 2: Progrip |
Primary outcome
Number of contacts due to postoperative pain
Time frame: 3 months
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation
3 secondary outcomes
The use of pain medication
Time frame: 1 year
Pain intensity
Time frame: 1 year
Number of contacts
Time frame: 1 year
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 2 May 2022.
- Derived from this study: PubMed 37733083Tholix AM, Kossi J, Harju J. One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial. Langenbecks Arch Surg. 2023 Sep 21;408(1):369. doi: 10.1007/s00423-023-03106-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesix mesh and Progrip mesh in people with Pain, Postoperative and Inguinal Hernia, run by Helsinki University Central 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 10 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 2 May 2022. 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?
Number of contacts due to postoperative pain (time frame: 3 months). 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 NCT03734224, 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 2 May 2022.