Incisional Hernia Progression Over Time (INPRO)
Primary Purpose
Hernia, Ventral
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Repeated computed tomography scan of abdomen
Sponsored by
About this trial
This is an interventional diagnostic trial for Hernia, Ventral
Eligibility Criteria
Inclusion Criteria:
- Suspected incisional hernia with a horizontal fascial defect > 7 cm
Exclusion Criteria:
- Inability to read or speak Danish
Sites / Locations
- Digestive Disease Center, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ventral incisional hernia
Arm Description
Repeated computed tomography scan of abdomen
Outcomes
Primary Outcome Measures
Fascial defect area
Change fascial defect area from initial CT scan to follow-up CT scan
Secondary Outcome Measures
Hernia-related quality of life
Change in Hernia-related quality of life
Physical activity
Change in physical activity, measured by International Physical Activity Questionnaire
Hernia sac volume
Change in hernia sac volume measured on repeated CT scans
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02616718
Brief Title
Incisional Hernia Progression Over Time
Acronym
INPRO
Official Title
Incisional Hernia Progression Over Time
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ventral incisional hernia
Arm Type
Experimental
Arm Description
Repeated computed tomography scan of abdomen
Intervention Type
Radiation
Intervention Name(s)
Repeated computed tomography scan of abdomen
Intervention Description
Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan
Primary Outcome Measure Information:
Title
Fascial defect area
Description
Change fascial defect area from initial CT scan to follow-up CT scan
Time Frame
28-32 weeks
Secondary Outcome Measure Information:
Title
Hernia-related quality of life
Description
Change in Hernia-related quality of life
Time Frame
28-32 weeks
Title
Physical activity
Description
Change in physical activity, measured by International Physical Activity Questionnaire
Time Frame
28-32 weeks
Title
Hernia sac volume
Description
Change in hernia sac volume measured on repeated CT scans
Time Frame
28-32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected incisional hernia with a horizontal fascial defect > 7 cm
Exclusion Criteria:
Inability to read or speak Danish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian K Jensen, MD
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Disease Center, Bispebjerg Hospital
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Incisional Hernia Progression Over Time
We'll reach out to this number within 24 hrs