Incisional Hernia Progression Over Time (INPRO)

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral
• Intervention / Treatment: Radiation: Repeated computed tomography scan of abdomen

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Copenhagen NV, Copenhagen, Denmark, DK-2400
      • Digestive disease center, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Suspected incisional hernia with a horizontal fascial defect > 7 cm

Exclusion Criteria:

• Inability to read or speak Danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventral incisional hernia; Repeated computed tomography scan of abdomen	Radiation: Repeated computed tomography scan of abdomen; Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fascial defect area	Change fascial defect area from initial CT scan to follow-up CT scan	28-32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia-related quality of life	Change in Hernia-related quality of life	28-32 weeks
Physical activity	Change in physical activity, measured by International Physical Activity Questionnaire	28-32 weeks
Hernia sac volume	Change in hernia sac volume measured on repeated CT scans	28-32 weeks

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Kristian K Jensen, MD, Bispebjerg Hospital, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: November 21, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: H-15008340