Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy

Not Applicable

Recruiting

• Conditions: Cholecystitis; Gall Stone

• Registration Number: NCT05376540
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-17
• Status Verified: 2023-03
• Study Start: 2023-03-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Indication for laparoscopic cholecystectomy
• Signed informed consent

Exclusion Criteria

• Allergy to indocyanine green or iodine
• Pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A questionnaire will be used to evaluate the surgeons experience.	3-4 months	This study aims to compare the surgeons subjective experience of ICG utility for different dosages and route of administration of indocyanine green in patients operated with laparoscopic cholecystectomy. A questionnaire will be used to evaluate the surgeons experience.

Trial Locations

Locations (1)

Østfold Hospital trust; 🇳🇴 Moss, Norway