Cholecystitis Clinical Trial
— TROSELCIIOfficial title:
Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Verified date | November 2022 |
Source | Attikon Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
Status | Completed |
Enrollment | 100 |
Est. completion date | November 22, 2022 |
Est. primary completion date | November 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - All patients requiring PC, regardless of the underlying cause. - Signed informed consent form Exclusion Criteria: - Age <18 years or >100 years - The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician - Severe uncontrollable coagulopathy |
Country | Name | City | State |
---|---|---|---|
Greece | "Attikon" University General Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Attikon Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical success | Image verified catheter placement within the gallbladder and subsequent bile aspiration | At the end of the procedure | |
Primary | Procedure-related complications | Minor or major complications attributed to the procedure | 3 months | |
Secondary | Duration of the procedure | The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder | Intraprocedural | |
Secondary | Intraprocedural pain | pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score | End of the procedure | |
Secondary | Post-procedural pain | Pain experienced up to12 hours after procedure assessed using a standard visual analogue score (VAS - Visual Analog Scale 0-10, 0 representing no pain & 10 representing worst pain experienced) | 12 hours | |
Secondary | Clinical success | Gradual subsidence of signs, symptoms, and elevated inflammatory markers | 72 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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