An observational study in Emergency Inguinal Hernia Repair and Emergency Ventral Hernia Repair, sponsored by Oulu University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Oulu University Hospital · Observational
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.
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 Existing guidelines are partly outdated and largely based on expert opinion.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.
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
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's planned enrollment of 600 is above the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients, who will undergo emergency ventral or inguinal hernia repair between Oct 1st 2025 and Sep 31st 2027 in participating hospitals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients, who will have their ventral or inguinal hernia repaired in emergency surgery
Procedure: Emergency hernia repair
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.
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
Time frame: 2 years
Surgical site infection rate 30 days after surgery
Surgical site infection as described by Centers for Disease Control and Prevention
Time frame: 30 days
Incidence of Postoperative complications 30 after the surgery
Surgical complications graded by Clavien-Dindo Classification
Time frame: 30 days
Number of patients who died 30 days after the surgery
Death after the surgery
Time frame: 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
Time frame: 5 years
Quality of life RAND-36
Quality of life measured by RAND-36
Time frame: 5 years
Quality of life Activities Assessment Scale
Quality of life measured by Activities Assessment Scale
Time frame: 5 years
Quality of life PROMIS
Quality of life measured by promis
Time frame: 5 years
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Oulu University Hospital