Clinical trial NCT02616718: Incisional Hernia Progression Over Time
Official title: Incisional Hernia Progression Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to read or speak Danish

Primary outcomes:
measure: Fascial defect area
timeFrame: 28-32 weeks
Secondary outcomes:
measure: Hernia-related quality of life
timeFrame: 28-32 weeks
measure: Physical activity
timeFrame: 28-32 weeks
measure: Hernia sac volume
timeFrame: 28-32 weeks
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Digestive Disease Center, Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Bispebjerg Hospital, University of Copenhagen
name: Kristian K Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: