Quality Control of Ventral Hernia Surgery by Prospective Registration

Ventral Incisional Hernia Clinical Trial

Official title:

Quality Control of Ventral Hernia Surgery in 21 Belgian Hospitals by Prospective Registration in Close Collaboration With the Danish Hernia Database.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04624100
• Other study ID #: S62600
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia)

• Male and female

• 18 years or older

• Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating Belgian hospitals, but by specific surgeons)

• Elective and emergency surgery

• Signed informed consent form

Exclusion criteria

• Younger than 18 years

• Not operated or supervised by participating surgeon

• Pregnant at inclusion in the registry

• No signed informed consent form

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Incisional Hernia

Intervention

Procedure:
• Hernia repair
Primary or mesh repair of primary ventral or incisional hernia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Belgian Section for Abdominal Wall Surgery, section of the Royal Belgian Society for Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	reoperation and readmission rate for (mesh-related) complications or recurrence related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh-related) complications or recurrence	through study completion, an average of 2 years