Incisional Hernia Progression Over Time

NCT ID: NCT02616718

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-04-30

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.

Conditions

Hernia, Ventral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ventral incisional hernia

Repeated computed tomography scan of abdomen

Group Type: EXPERIMENTAL

Repeated computed tomography scan of abdomen

Intervention Type: RADIATION

Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Inability to read or speak Danish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristian Kiim Jensen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristian K Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, University of Copenhagen

Locations

Digestive Disease Center, Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

H-15008340

Identifier Type: -

Identifier Source: org_study_id