A comparison of time taken for gallbladder removal surgery (cholecystectomy) by two methods (conventional laparoscopic technique versus fluorescent laparoscopic technique) in patients of gallbladder stone disease.

Conventional versus fluorescent laparoscopic cholecystectomy in a tertiary care hospital - a randomized controlled Clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067266

Enrollment

120

Registered

2024-05-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fluorescence laparoscopic cholecystectomy: Indocyanine green dye 0.4mg/ml/kg body weight will be injected intra-venously after skin sensitivity test 40 minutes before the surgery. Near

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing laparoscopic cholecystectomy surgery.

Exclusion criteria

Exclusion criteria: 1. Jaundice. 2. Gall bladder malignancy. 3. Pregnancy 4. Any deviation from the proposed procedure of laparoscopic cholecystectomy. 5. Equipment failure effecting the duration of surgery. 6. Contraindications to the use of indocyanine green dye including known allergy to the agent. 7. Pre-existing medical conditions or surgical history that may significantly impact the operative time or compromise patient safety. 8. Conversion to open cholecystectomy.

Design outcomes

Primary

Measure	Time frame
Duration of surgery in minutes (from first incision/ port to closure of last incision/ port)Timepoint: at the start and at the end of the surgery (closure of the last port)	—

Secondary

Measure	Time frame
1. Various complications of ICG dye administration 2. Difference in time taken during different surgical steps a. Time duration from gallbladder retraction to dissection of Calot’s triangle & achievement of Strassberg’s critical view of safety b. Time duration from cystic duct division to dissection of gallbladder from liver bed 3. Subgroup analysis of difference of operative duration between techniques based on anthropometry, demography, sonological findings & Nassar & Cuschieri difficulty grades.Timepoint: 1. During & after the surgery (for first secondary outcome) 2. At the start, during & at the end of the surgery (for second secondary outcome) 3. During analysis (Post-hoc analysis) (for 3rd secondary outcome)	—

Measure

Time frame

1. Various complications of ICG dye administration 2. Difference in time taken during different surgical steps a. Time duration from gallbladder retraction to dissection of Calot’s triangle & achievement of Strassberg’s critical view of safety b. Time duration from cystic duct division to dissection of gallbladder from liver bed 3. Subgroup analysis of difference of operative duration between techniques based on anthropometry, demography, sonological findings & Nassar & Cuschieri difficulty grades.Timepoint: 1. During & after the surgery (for first secondary outcome) 2. At the start, during & at the end of the surgery (for second secondary outcome) 3. During analysis (Post-hoc analysis) (for 3rd secondary outcome)

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Countries

India

Contacts

Public ContactDr Subhajit datta

Sikkim Manipal Institute of Medical Sciences

kumar.nishant@smims.smu.edu.in8670679466

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026