Emergency hernia repair
ProcedurePatients 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.
NCT Number: NCT07314398
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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 Existing guidelines are partly outdated and largely based on expert opinion.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.
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.
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.
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.
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.
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
Either clinical or radiological recurrent hernia
Time frame: 30 days
Surgical site infection as described by Centers for Disease Control and Prevention
Time frame: 30 days
Surgical complications graded by Clavien-Dindo Classification
Time frame: 30 days
Death after the surgery
Time frame: 5 years
Reoperations due to recurrent hernia, mesh or other operations at the previous hernia site
Time frame: 5 years
Quality of life measured by RAND-36
Time frame: 5 years
Quality of life measured by Activities Assessment Scale
Time frame: 5 years
Quality of life measured by promis
Oulu University Hospital
Other
Prospective Cohort Study on Surgical Methods and Outcomes in Emergency Groin and Ventral Hernia Repairs in Finland
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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