Incisional Hernia Progression Over Time

Hernia, Ventral Clinical Trial

— INPRO  

Official title:

Incisional Hernia Progression Over Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616718
• Other study ID #: H-15008340
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 30, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to read or speak Danish

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Denmark	Digestive Disease Center, Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fascial defect area	Change fascial defect area from initial CT scan to follow-up CT scan	28-32 weeks
Secondary	Hernia-related quality of life	Change in Hernia-related quality of life	28-32 weeks
Secondary	Physical activity	Change in physical activity, measured by International Physical Activity Questionnaire	28-32 weeks
Secondary	Hernia sac volume	Change in hernia sac volume measured on repeated CT scans	28-32 weeks