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Clinical Trials/NCT02616718
NCT02616718CompletedNot Applicable

Incisional Hernia Progression Over Time

Bispebjerg Hospital2 sites in 1 country35 target enrollmentStarted: September 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
2
Primary Endpoint
Fascial defect area

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Inability to read or speak Danish

Arms & Interventions

Ventral incisional hernia

Experimental

Repeated computed tomography scan of abdomen

Intervention: Repeated computed tomography scan of abdomen (Radiation)

Outcomes

Primary Outcomes

Fascial defect area

Time Frame: 28-32 weeks

Change fascial defect area from initial CT scan to follow-up CT scan

Secondary Outcomes

  • Hernia sac volume(28-32 weeks)
  • Hernia-related quality of life(28-32 weeks)
  • Physical activity(28-32 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kristian Kiim Jensen

MD

Bispebjerg Hospital

Study Sites (2)

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