Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330688
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-22
Brief Title:
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound US-guided percutaneous cholecystostomy PC with the trocar technique by the patients bedside
Detailed Description:
This clinical study will include patients who will undergo US-guided PC with the trocar technique The study will include all cases requiring PC regardless of the underlying cause while those requiring computed tomography CT guidance and those with uncontrolled coagulation disorders will be excluded
Patient demographics height weight and body mass index BMI comorbidities ASA score presence or absence of stones presence or absence of gallbladder perforation at diagnosis presence or absence of concomitant ascitic effusion days of preoperative antibiotic treatment imaging modality used to establish the diagnosis technical details of the procedure laboratory values before and after surgery and contact information for patient monitoring will be recorded
The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated In addition the anatomical access route during the PC transhepatictransperitoneal and intercostalsubcostal the duration of the operation the intraoperative and postoperative pain and the clinical success of the method will be recorded
After the operation the patients will be monitored clinically and with laboratory test and if deemed necessary US CT or both imaging will be performed Before discharge written instructions will be given regarding the management and care of the catheter
This study will not burden the hospital financially as the clinical laboratory and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure the technique used to perform the procedure as well as the monitoring of the patients and the possible complications of the procedure are part of the hospitals routine
Patient demographics height weight and body mass index BMI comorbidities ASA score presence or absence of stones presence or absence of gallbladder perforation at diagnosis presence or absence of concomitant ascitic effusion days of preoperative antibiotic treatment imaging modality used to establish the diagnosis technical details of the procedure laboratory values before and after surgery and contact information for patient monitoring will be recorded
The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated In addition the anatomical access route during the PC transhepatictransperitoneal and intercostalsubcostal the duration of the operation the intraoperative and postoperative pain and the clinical success of the method will be recorded
After the operation the patients will be monitored clinically and with laboratory test and if deemed necessary US CT or both imaging will be performed Before discharge written instructions will be given regarding the management and care of the catheter
This study will not burden the hospital financially as the clinical laboratory and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure the technique used to perform the procedure as well as the monitoring of the patients and the possible complications of the procedure are part of the hospitals routine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None