70
Participants
Start Date
November 1, 2022
Primary Completion Date
October 1, 2026
Study Completion Date
June 1, 2027
Endoscopic Coeliac Artery Release (eCAR)
Endoscopic Coeliac Artery Release (eCAR); The Median Arcuate Ligament will be cleaved via an endoscopic retroperitoneal approach using a 4 trocar technique described in detail by van Petersen (12). To rule out learning curves and procedural variation all the procedures will be performed by two experienced eCAR surgeons in the MST-Dutch Expert Centre of Gastrointestinal Ischemia. All procedures will be videotaped. Both eCAR surgeons will not be involved in the follow up procedures.
Sham Operation
The sham operation consists of making 4 incisions up to the fascia similar to endoscopic AC release (eCAR). After 60 to 75 minutes of general anesthesia, in accordance with the average operating time of eCAR, the sham operation is ended. This study design allows for patient and observer blinding and for the sham group the eCAR approach is still feasible if the CARoSO outcome support this without applying additional scar tissue.
RECRUITING
Medisch Spectrum Twente, Enschede
Collaborators (1)
Medical School Medisch Spectrum Twente
UNKNOWN
Techmed University of Twente
UNKNOWN
Erasmus Medical Centre
UNKNOWN
Medisch Spectrum Twente
OTHER