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Incisional Hernia Progression Over Time

Incisional Hernia Progression Over Time

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02616718
Acronym
INPRO
Enrollment
35
Registered
2015-11-30
Start date
2015-09-30
Completion date
2018-04-30
Last updated
2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral

Brief summary

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia. If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan). If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

Detailed description

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia. If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan). In case no baseline scan in hernia protocol exists, patients will undergo this scan immediately after inclusion in the study. Furthermore, patients will be asked to fill out a questionnaire on physical activity (IPAQ) and hernia-related quality of life (HerQLes) at the time of the baseline and follow-up scans. IPAQ is a well-validated questionnaire, which assesses patients' physical activity within the last 7 days. The outcome is metabolic minutes per week, a numerical value which places the responder in one of three categories: Low, moderate or high physical activity. HerQLes is a validated questionnaire assessing the hernia-related quality of life. This questionnaire has been translated into Danish using a standardized protocol. The outcome is a numerical score of 0-100, with 100 being the highest hernia-related quality of life. Currently, the time from planning of hernia repair to surgery is approximately 30 weeks. Thus, the mean time between the two CT scans should be around 28-32 weeks. If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

Interventions

RADIATIONRepeated computed tomography scan of abdomen

Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Suspected incisional hernia with a horizontal fascial defect \> 7 cm

Exclusion criteria

* Inability to read or speak Danish

Design outcomes

Primary

MeasureTime frameDescription
Fascial defect area28-32 weeksChange fascial defect area from initial CT scan to follow-up CT scan

Secondary

MeasureTime frameDescription
Hernia sac volume28-32 weeksChange in hernia sac volume measured on repeated CT scans
Hernia-related quality of life28-32 weeksChange in Hernia-related quality of life
Physical activity28-32 weeksChange in physical activity, measured by International Physical Activity Questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026