Success of Intraoperative Cholangiography

Completed

• Conditions: Choledocholithiasis; Cholecystolithiasis
• Interventions: Radiation: intraoperative cholangiography

• Registration Number: NCT04052633
• Lead Sponsor: Jyväskylä Central Hospital

Brief Summary

The purpose of the present study was to evaluate the success of routine use of intraoperative cholangiography (IOC ) and to examine the factors that are hindering the performance of intraoperative c-arm cholangiography.

Detailed Description

From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed were entered in a prospective database. IOC has been instructed to be performed routinely when feasible during cholecystectomy since 1998. All elective operations were performed either by residents or specialist surgeons. For this study the investigators collected the radiation exposure values from exposure and pulsed fluoroscopy. Fluoroscopy time (s) was recorded.The operating surgeon was asked to fulfill a questionnaire directly after the cholecystectomy. The technical success and reasons for possible deferral of IOC were documented.Patient data from unsuccessful or deferred cholangiography cases was checked 6 months after cholecystectomy for possible symptomatic residual choledocholithiasis.Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.

Ethics: The study was approved by the hospital administration.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Study First Submitted: 2019-03-30
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-07
• Last Update Submitted: 2019-08-07
• Study First Posted: 2019-08-12
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• all consecutive cholecystectomy patients during January 2018 to August 2018

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholangiography failure	intraoperative cholangiography	From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography
Cholangiography success	intraoperative cholangiography	From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography

Primary Outcome Measures

Name	Time	Method
number of intraoperative cholangiography	6 months	number of successful cannulation

Secondary Outcome Measures

Name	Time	Method
technical success of intraoperative cholangiography	6 months	grades of technical success ( easy, , minimal difficulties, major difficulties)

Trial Locations

Locations (1)

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland