Emergency Inguinal Hernia RepairNCT07314398
Emergency Hernia Repair
An observational study of Emergency Inguinal Hernia Repair and Emergency Ventral Hernia Repair, run by Oulu University Hospital.
Trial summary
Emergency hernia repairs are associated with significantly higher morbidity and mortality compared with elective hernia surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually, but treatment practices vary widely, and high-quality evidence is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Inguinal Hernia Repair, Emergency Ventral Hernia Repair
- What is being tested?
- Emergency hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Sep 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, who will undergo emergency ventral or inguinal hernia repair between Oct 1st 2025 and Sep 31st 2027 in participating hospitals
Who may be able to join
- Emergency repair of a groin or ventral hernia
Who cannot join
- Pregnancy
- Age under 18 years
- Advanced malignancy
- Inability to follow up (e.g., long travel distance or poor functional status)
- Participation in another study
- Lack of informed consent
About this study
Official title: Prospective Cohort Study on Surgical Methods and Outcomes in Emergency Groin and Ventral Hernia Repairs in Finland
Emergency hernia repairs are associated with significantly higher morbidity and mortality compared with elective hernia surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually, but treatment practices vary widely, and high-quality evidence is lacking.
This prospective multicenter cohort study will evaluate outcomes of emergency groin and ventral hernia repairs in Finland. About 600 patients will be recruited over two years and followed for five years postoperatively. The study will collect standardized data on patient demographics, comorbidities, surgical technique, intraoperative findings, postoperative course, and long-term follow-up. Quality of life will be assessed with RAND-36, AAS, and PROMIS questionnaires.
Read more
The primary endpoint is hernia recurrence within two years after surgery. Secondary outcomes include 30- and 90-day complications, infection rates, readmissions, recovery time, and quality of life at 1, 2, and 5 years.
The results will provide robust evidence to guide clinical practice, optimize surgical techniques, and refine urgency classification and surgeon competence requirements for emergency hernia repair.
Read the detailed description
- Introduction and Background Hernia surgery is among the most common surgical procedures, the majority performed as elective operations. However, the proportion of emergency procedures is considerable, and these are associated with significantly higher morbidity and mortality compared with elective surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually. Current treatment practices for emergency hernia surgery vary substantially, and scientific evidence on management and outcomes is lacking. Existing guidelines are partly outdated and largely based on expert opinion. The aim of this study is to provide new, scientifically robust evidence on the outcomes, complications, and postoperative quality of life following emergency hernia surgery.
- Study Objectives The primary objective is to assess the short- and long-term outcomes of different surgical techniques in emergency groin and ventral hernia repairs. Specifically, the study will evaluate: Surgical outcomes and complications within 30 and 90 days postoperatively Risk of recurrence and quality of life at 1, 2, and 5 years Impact of wound and mesh infections, as well as other postoperative factors, on recurrence Effectiveness and safety of different surgical techniques The results will support more evidence-based and precise recommendations on surgical methods, urgency classification, and the role of surgeon expertise.
- Study Design and Patient Cohort This is a multicenter study with a prospective patient cohort of emergency groin and ventral hernia repairs. Patients will be recruited over two years and followed up for five years postoperatively. The aim is to include as many eligible patients as possible. Inclusion criterion Emergency repair of a groin or ventral hernia Exclusion criteria Pregnancy Age under 18 years Advanced malignancy Inability to follow up (e.g., long travel distance or poor functional status) Participation in another study Lack of informed consent Estimated sample size: ~600 patients recruited across participating Finnish hospitals.
- Methods and Data Collection Data will be collected in the REDCap system at the following time points: Baseline (preoperative): Patient demographics (age, sex, BMI) and comorbidities Intraoperative: Surgical technique, procedures performed, duration of surgery Postoperative (hospital stay): Recovery, complications, reoperations Follow-up at 30 days, 90 days, 1, 2, and 5 years: Recurrence (clinically and with imaging if needed) Quality of life (RAND-36, AAS, PROMIS) Complications, readmissions, recovery time, sick leave Patients will be contacted by phone at each follow-up. If recovery is delayed, complications are suspected, or recurrence is possible, patients will be invited for further assessment at the hospital where the surgery was performed.
- Statistical Analysis The primary endpoint is hernia recurrence within two years after surgery. Statistical methods include: Kaplan-Meier analysis for comparison of surgical techniques Chi-square test and Fisher's exact test for categorical variables Student's t-test for continuous variables Multivariate analysis for independent risk factors Analyses will be conducted using IBM SPSS Statistics. A p-value < 0.05 will be considered statistically significant.
- Ethical Considerations and Data Protection The study has been approved by the Ethics Committee of the Wellbeing Services County of North Ostrobothnia. Local research permits will be obtained from each participating hospital before study initiation. Participation is voluntary, and written informed consent will be obtained from all patients. Clinical management will follow local treatment protocols regardless of study participation. Patient data will be stored in a pseudonymized form. The data controller is the Wellbeing Services County of North Ostrobothnia.
- Timeline
2024-2026: Patient recruitment and initiation of follow-up. Study start date: 1 September 2025 across all participating hospitals.
2028: Data analysis and first publication on the primary endpoint
2031: Completion of follow-up and publication of long-term outcomes
- Being tested
- Emergency hernia repair
- Keywords
- inguinal hernia, ventral hernia, emergency surgery
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency hernia repairProcedure or surgery
Patients who will have either their ventral or inguinal hernia repaired in emergency surgery. The techniques are not standardized, but the details will be collected to prospective database.
| Study group | Role | What they receive |
|---|---|---|
| Emergency ventral or inguinal hernia repair | Patients, who will have their ventral or inguinal hernia repaired in emergency surgery Receives: Procedure: Emergency hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hernia recurrence
Either clinical or radiological recurrent hernia
- Risk of recurrence and quality of life at 1, 2, and 5 years
- Impact of wound and mesh infections, as well as other postoperative factors, on recurrence
- Effectiveness and safety of different surgical techniques
Measured: 2 years
Secondary outcomes (7)
Surgical site infection rate 30 days after surgery
Surgical site infection as described by Centers for Disease Control and Prevention
Measured: 30 days
Incidence of Postoperative complications 30 after the surgery
Surgical complications graded by Clavien-Dindo Classification
Measured: 30 days
Number of patients who died 30 days after the surgery
Death after the surgery
Measured: 30 days
Incidence of hernia related re-operations during the 5 years' follow-up
Reoperations due to recurrent hernia, mesh or other operations at the previous hernia site
Measured: 5 years
Quality of life RAND-36
Quality of life measured by RAND-36
Measured: 5 years
Quality of life Activities Assessment Scale
Quality of life measured by Activities Assessment Scale
Measured: 5 years
Quality of life PROMIS
Quality of life measured by promis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Inguinal Hernia RepairStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314398
- Sponsor's protocol ID
- 50/2023
- Status last verified
- Oct 2025
- First submitted
- 1 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due to Finnish laws on privacy protection but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Surgical Methods and Outcomes in Emergency Groin and Ventral Hernia Repairs in Finland
- ClinicalTrials.gov ID
- NCT07314398
- Acronym / sponsor ID
- 50/2023
- Keywords
- inguinal hernia, ventral hernia, emergency surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 2 Jan 2026 (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.
Emergency hernia repairs are associated with significantly higher morbidity and mortality compared with elective hernia surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually, but treatment practices vary widely, and high-quality evidence is lacking.
This prospective multicenter cohort study will evaluate outcomes of emergency groin and ventral hernia repairs in Finland. About 600 patients will be recruited over two years and followed for five years postoperatively. The study will collect standardized data on patient demographics, comorbidities, surgical technique, intraoperative findings, postoperative course, and long-term follow-up. Quality of life will be assessed with RAND-36, AAS, and PROMIS questionnaires.
The primary endpoint is hernia recurrence within two years after surgery. Secondary outcomes include 30- and 90-day complications, infection rates, readmissions, recovery time, and quality of life at 1, 2, and 5 years.
The results will provide robust evidence to guide clinical practice, optimize surgical techniques, and refine urgency classification and surgeon competence requirements for emergency hernia repair.
Detailed description
- Introduction and Background Hernia surgery is among the most common surgical procedures, the majority performed as elective operations. However, the proportion of emergency procedures is considerable, and these are associated with significantly higher morbidity and mortality compared with elective surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually. Current treatment practices for emergency hernia surgery vary substantially, and scientific evidence on management and outcomes is lacking. Existing guidelines are partly outdated and largely based on expert opinion. The aim of this study is to provide new, scientifically robust evidence on the outcomes, complications, and postoperative quality of life following emergency hernia surgery.
- Study Objectives The primary objective is to assess the short- and long-term outcomes of different surgical techniques in emergency groin and ventral hernia repairs. Specifically, the study will evaluate: Surgical outcomes and complications within 30 and 90 days postoperatively Risk of recurrence and quality of life at 1, 2, and 5 years Impact of wound and mesh infections, as well as other postoperative factors, on recurrence Effectiveness and safety of different surgical techniques The results will support more evidence-based and precise recommendations on surgical methods, urgency classification, and the role of surgeon expertise.
- Study Design and Patient Cohort This is a multicenter study with a prospective patient cohort of emergency groin and ventral hernia repairs. Patients will be recruited over two years and followed up for five years postoperatively. The aim is to include as many eligible patients as possible. Inclusion criterion Emergency repair of a groin or ventral hernia Exclusion criteria Pregnancy Age under 18 years Advanced malignancy Inability to follow up (e.g., long travel distance or poor functional status) Participation in another study Lack of informed consent Estimated sample size: ~600 patients recruited across participating Finnish hospitals.
- Methods and Data Collection Data will be collected in the REDCap system at the following time points: Baseline (preoperative): Patient demographics (age, sex, BMI) and comorbidities Intraoperative: Surgical technique, procedures performed, duration of surgery Postoperative (hospital stay): Recovery, complications, reoperations Follow-up at 30 days, 90 days, 1, 2, and 5 years: Recurrence (clinically and with imaging if needed) Quality of life (RAND-36, AAS, PROMIS) Complications, readmissions, recovery time, sick leave Patients will be contacted by phone at each follow-up. If recovery is delayed, complications are suspected, or recurrence is possible, patients will be invited for further assessment at the hospital where the surgery was performed.
- Statistical Analysis The primary endpoint is hernia recurrence within two years after surgery. Statistical methods include: Kaplan-Meier analysis for comparison of surgical techniques Chi-square test and Fisher's exact test for categorical variables Student's t-test for continuous variables Multivariate analysis for independent risk factors Analyses will be conducted using IBM SPSS Statistics. A p-value < 0.05 will be considered statistically significant.
- Ethical Considerations and Data Protection The study has been approved by the Ethics Committee of the Wellbeing Services County of North Ostrobothnia. Local research permits will be obtained from each participating hospital before study initiation. Participation is voluntary, and written informed consent will be obtained from all patients. Clinical management will follow local treatment protocols regardless of study participation. Patient data will be stored in a pseudonymized form. The data controller is the Wellbeing Services County of North Ostrobothnia.
- Timeline
2024-2026: Patient recruitment and initiation of follow-up. Study start date: 1 September 2025 across all participating hospitals.
2028: Data analysis and first publication on the primary endpoint
2031: Completion of follow-up and publication of long-term outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency ventral or inguinal hernia repair | – | Procedure: Emergency hernia repairPatients, who will have their ventral or inguinal hernia repaired in emergency surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, who will undergo emergency ventral or inguinal hernia repair between Oct 1st 2025 and Sep 31st 2027 in participating hospitals
Key inclusion criteria (1 listed)
- Emergency repair of a groin or ventral hernia
Key exclusion criteria (6 listed)
- Pregnancy
- Age under 18 years
- Advanced malignancy
- Inability to follow up (e.g., long travel distance or poor functional status)
- Participation in another study
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 |
|---|---|---|
| Emergency hernia repairPatients who will have either their ventral or inguinal hernia repaired in emergency surgery. The techniques are not standardized, but the details will be collected to prospective database. | Procedure or surgery | Emergency ventral or inguinal hernia repair |
Primary outcome
Number of patients with hernia recurrence
Time frame: 2 years
Either clinical or radiological recurrent hernia * Risk of recurrence and quality of life at 1, 2, and 5 years * Impact of wound and mesh infections, as well as other postoperative factors, on recurrence * Effectiveness and safety of different surgical techniques
7 secondary outcomes
Surgical site infection rate 30 days after surgery
Time frame: 30 days
Incidence of Postoperative complications 30 after the surgery
Time frame: 30 days
Number of patients who died 30 days after the surgery
Time frame: 30 days
Incidence of hernia related re-operations during the 5 years' follow-up
Time frame: 5 years
Quality of life RAND-36
Time frame: 5 years
Quality of life Activities Assessment Scale
Time frame: 5 years
Quality of life PROMIS
Time frame: 5 years
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 2 Jan 2026.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due to Finnish laws on privacy protection but are available from the corresponding author on reasonable request.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Inguinal Hernia Repair and Emergency Ventral Hernia Repair, run by Oulu University Hospital.
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 6 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 patients with hernia recurrence (time frame: 2 years). 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 2 Jan 2026.