Emergency Hernia Repair

NCT ID: NCT07314398

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2032-09-30

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 Existing guidelines are partly outdated and largely based on expert opinion.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

Conditions

Emergency Inguinal Hernia Repair; Emergency Ventral Hernia Repair

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Emergency ventral or inguinal hernia repair

Patients, who will have their ventral or inguinal hernia repaired in emergency surgery

Emergency hernia repair

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

50/2023

Identifier Type: -

Identifier Source: org_study_id