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Emergency Hernia Repair

Prospective Cohort Study on Surgical Methods and Outcomes in Emergency Groin and Ventral Hernia Repairs in Finland

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07314398
Enrollment
600
Registered
2026-01-02
Start date
2026-02-01
Completion date
2032-09-30
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Inguinal Hernia Repair, Emergency Ventral Hernia Repair

Keywords

inguinal hernia, ventral hernia, emergency surgery

Brief 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. 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

1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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

Interventions

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.

Sponsors

Oulu University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with hernia recurrence2 yearsEither 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

Secondary

MeasureTime frameDescription
Incidence of Postoperative complications 30 after the surgery30 daysSurgical complications graded by Clavien-Dindo Classification
Number of patients who died 30 days after the surgery30 daysDeath after the surgery
Incidence of hernia related re-operations during the 5 years' follow-up5 yearsReoperations due to recurrent hernia, mesh or other operations at the previous hernia site
Surgical site infection rate 30 days after surgery30 daysSurgical site infection as described by Centers for Disease Control and Prevention
Quality of life Activities Assessment Scale5 yearsQuality of life measured by Activities Assessment Scale
Quality of life PROMIS5 yearsQuality of life measured by promis
Quality of life RAND-365 yearsQuality of life measured by RAND-36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026