Incisional Hernia Progression Over Time

NCT02616718 | Completed DMC

• 1 other identifier: H-15008340
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Ventral

Outcome Measures

Primary Outcomes (1)

• Fascial defect area

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

  28-32 weeks

Secondary Outcomes (3)

• Hernia-related quality of life

  28-32 weeks

• Physical activity

  28-32 weeks

• Hernia sac volume

  28-32 weeks

Study Arms (1)

Ventral incisional hernia

EXPERIMENTAL

Repeated computed tomography scan of abdomen

Radiation: Repeated computed tomography scan of abdomen

Interventions

Repeated computed tomography scan of abdomen RADIATION

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

Ventral incisional hernia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to read or speak Danish

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Digestive Disease Center, Bispebjerg Hospital

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristian K Jensen, MD

  Bispebjerg Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: November 30, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: April 30, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

DK (1)