Status:
UNKNOWN
Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction
Lead Sponsor:
University College, London
Collaborating Sponsors:
University College London Hospitals
Conditions:
Ventral Hernia
Abdominal Wall Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure ha...
Eligibility Criteria
Inclusion
- Patients with midline hernia defects. Only patients with one or more midline defect will be included. For our study, we will define a midline hernia as herniation through the linea alba and with the rectus muscles falling either side of the hernia. The pre-operative CT scan will be used to study the hernia morphology and to see whether the patient fulfills these criteria.
- Patients undergoing primary or incisional ventral hernia repair, without formation of or closure of a stoma.
- Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%, as measured on their pre-operative CT or MRI scan. The loss of domain will be measured using the patients' preoperative CT or MRI scan following the method of Tanaka et al.
- Patients aged ≥ 18 years old.
- Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation. Any reconstruction technique can be used (e.g. anterior or posterior component separation) as long as primary fascial closure is achieved. The mesh may be placed in either the retro-rectus position (with or without a transverse abdominis release) or the onlay position.
- Participants who have a synthetic or bio-synthetic mesh implanted.
- Midline ventral hernias of VHWG grade 2 or 3. Clean and or Clean-contaminated wound classification.
- The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to take part and has duly signed the consent form.
Exclusion
- Emergency/Redo surgery.
- Defects not in the midline. Patients with one or more defect not through the linea alba on the pre-operative CT scan.
- AWR for abdominal wall sarcoma, invasive intra-abdominal carcinoma or other malignant disease.
- Contaminated VHWG grade 4 hernias. Or Contaminated or Dirty wound according to the CDC wound classification system.
- Concomitant procedures such as bowel resection.
- The hernia requires a bridged repair.
- Individuals with co-morbid respiratory disease requiring oral corticosteroids or home oxygen therapy.
- Individuals who require the mesh to be placed in the intra-abdominal position.
- A patient with active peritonitis or an active mesh or subcutaneous infection.
- Individuals with a diagnosis of Crohn's disease.
- Individuals of American Society of Anesthesiology grade 4 or 5.
- Complete removal of an existing synthetic mesh (or biosynthetic mesh if not absorb) from a prior hernia repair in the same location is not possible.
- Participants with human immunodeficiency virus (HIV), known liver cirrhosis or alcohol abuse with a known relapse within 12 months.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03296475
Start Date
January 9 2018
End Date
December 1 2021
Last Update
May 31 2018
Active Locations (1)
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1
Univeristy College London
London, United Kingdom, NW1 2BU