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NCT Number: NCT07314398

Emergency Hernia Repair

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.

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Key information

About this study

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 Existing guidelines are partly outdated and largely based on expert opinion.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

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency hernia repair

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.

Primary outcomes

  1. Number of patients with hernia recurrence

    Time frame: 2 years

    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

Secondary outcomes

  1. Surgical site infection rate 30 days after surgery

    Time frame: 30 days

    Surgical site infection as described by Centers for Disease Control and Prevention

  2. Incidence of Postoperative complications 30 after the surgery

    Time frame: 30 days

    Surgical complications graded by Clavien-Dindo Classification

  3. Number of patients who died 30 days after the surgery

    Time frame: 30 days

    Death after the surgery

  4. Incidence of hernia related re-operations during the 5 years' follow-up

    Time frame: 5 years

    Reoperations due to recurrent hernia, mesh or other operations at the previous hernia site

  5. Quality of life RAND-36

    Time frame: 5 years

    Quality of life measured by RAND-36

  6. Quality of life Activities Assessment Scale

    Time frame: 5 years

    Quality of life measured by Activities Assessment Scale

  7. Quality of life PROMIS

    Time frame: 5 years

    Quality of life measured by promis

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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