Emergency Hernia Repair

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergency Inguinal Hernia Repair; Emergency Ventral Hernia Repair
• Intervention / Treatment: Procedure: 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 Existing guidelines are partly outdated and largely based on expert opinion.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

• Study Type: Observational
• Enrollment (Estimated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients, who will undergo emergency ventral or inguinal hernia repair between Oct 1st 2025 and Sep 31st 2027 in participating hospitals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Emergency ventral or inguinal hernia repair; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection rate 30 days after surgery	Surgical site infection as described by Centers for Disease Control and Prevention	30 days
Incidence of Postoperative complications 30 after the surgery	Surgical complications graded by Clavien-Dindo Classification	30 days
Number of patients who died 30 days after the surgery	Death after the surgery	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	5 years
Quality of life RAND-36	Quality of life measured by RAND-36	5 years
Quality of life Activities Assessment Scale	Quality of life measured by Activities Assessment Scale	5 years
Quality of life PROMIS	Quality of life measured by promis	5 years

Collaborators and Investigators

• Sponsor: Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ventral hernia; emergency surgery; inguinal hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal; Hernia, Ventral
• Other Study ID Numbers: 50/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No