NCT07314398

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Feb 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Sep 2032

First Submitted

Initial submission to the registry

September 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2032

Last Updated

January 2, 2026

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

September 1, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

inguinal herniaventral herniaemergency surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Surgical site infection rate 30 days after surgery

    30 days

  • Incidence of Postoperative complications 30 after the surgery

    30 days

  • Number of patients who died 30 days after the surgery

    30 days

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

    5 years

  • Quality of life RAND-36

    5 years

  • +2 more secondary outcomes

Study Arms (1)

Emergency ventral or inguinal hernia repair

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

Procedure: Emergency hernia repair

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.

Emergency ventral or inguinal hernia repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Emergency repair of a groin or ventral hernia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, InguinalHernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2025

First Posted

January 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2032

Last Updated

January 2, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.