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Published on: June 29, 2021
Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study
T M Hammond1, A Huang, K Prosser
1Centre for Academic Surgery, Institute of Cellular and Molecular Science, The Royal London Hospital, Barts and The London NHS Trust, Queen Mary School of Medicine and Dentistry, University of London, London, UK. t.hammond@qmul.ac.uk
Summary
A novel prophylactic collagen implant shows promise in preventing parastomal hernias. This study found no complications, suggesting a safer alternative to synthetic mesh for stoma reinforcement.
Area of Science:
- Surgical innovation
- Biomaterials science
- Gastroenterology
Background:
- Parastomal hernias are a common complication after stoma surgery.
- Synthetic mesh is used for prevention and repair but carries risks like infection and bowel erosion.
- A prophylactic collagen implant was investigated as a potentially safer alternative.
Purpose of the Study:
- To assess the safety and feasibility of a prophylactic collagen implant for parastomal hernia prevention.
- To evaluate the potential efficacy of the collagen implant in reducing parastomal hernia incidence.
- To compare outcomes with conventional stoma procedures.
Main Methods:
- Randomized controlled trial involving 20 patients undergoing defunctioning stomas.
- Patients were assigned to either conventional stoma creation or stoma reinforcement with a collagen implant.
- Follow-up included symptom questionnaires, clinical examination, ultrasound, and inflammatory markers.
Main Results:
- No parastomal hernias were observed in the 10 patients who received the collagen implant at 6.5 months median follow-up.
- Three of 10 patients in the conventional stoma group developed a parastomal hernia.
- No clinical complications, chronic seromas, or systemic inflammatory responses were detected.
Conclusions:
- Xenogeneic collagen implants are safe and feasible for soft tissue reinforcement.
- The collagen implant showed potential efficacy in preventing parastomal hernias.
- This approach offers a promising alternative to synthetic mesh, avoiding infection and bowel erosion risks.
