Parastomal Hernia Clinical Trial
Official title:
Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Parastomal hernia is a common complication to a stoma which can cause considerable suffering
for the patient. The conventional methods of repair available today have disappointing
results with high recurrence rates and serious complications. Some of the complications can
be related to the introduction of foreign material into the abdominal wall. The investigators
hypothesis is that the use of autologous full-thickness skin graft as reinforcement material
can offer an alternative with fewer complications and recurrences.
Patients with symptomatic parastomal hernia will be included in a prospective randomized
multicenter study comparing reinforcement with conventional synthetic mesh (with the best
available technique today), to full thickness skin grafts placed in an intraperitoneal
position. The intervention will be blinded to the participants, nursing staff and the
follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring
complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and
calculations will be done on the health economics.
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|---|---|---|---|
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