Coeliac Artery Release or Sham Operation

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

October 1, 2026

Study Completion Date

June 1, 2027

Conditions
Mesenteric IschemiaMedian Arcuate Ligament SyndromeDunbar SyndromeCoeliac Artery CompressionCeliac Artery Compression Syndrome
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

Unknown

RECRUITING

Medisch Spectrum Twente, Enschede

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical School Medisch Spectrum Twente

UNKNOWN

collaborator

Techmed University of Twente

UNKNOWN

collaborator

Erasmus Medical Centre

UNKNOWN

lead

Medisch Spectrum Twente

OTHER