Comparison of 4K laparoscopy with HD laparoscopy in patients undergoing laparoscopic cholecystectomy

Comparison of ultra-high-definition (4K) laparoscopy with conventional High Definition laparoscopy for intraoperative adverse events in patients undergoing laparoscopic cholecystectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040334

Enrollment

Registered

2022-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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: Ultra-high-definition (4K) Laparoscope system: Each Laparoscopic cholecystectomy performed with ultra-high-defintion (4K) laparoscope system will be recorded including the duration of s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients > 18 years of age having symptomatic gallstones 2. ASA grade I and grade II

Exclusion criteria

Exclusion criteria: 1. Acute Cholecystitis/Gangrenous Cholecystitis 2. Gallbladder malignancy 3. Prior failed attempt of laparoscopic cholecystectomy 4. Cholecystectomy combined with any additional procedure 5. Patients on immunosuppressive agents, steroids and antipsychotic drugs 6. Patienta allergic to Paracetamol

Design outcomes

Primary

Measure	Time frame
Duration of surgery measured in minutesTimepoint: Duration of surgery measured from the time of laparoscope camera placement through the initial access port upto the time of placement of the last skin approximation suture. (Total duration of surgery will be monitored at the completion of the procedure on the day of surgery)	—

Secondary

Measure	Time frame
Duration of postoperative hospitalisationTimepoint: Day of surgery will be counted as zero and calculated upto the day of discharge from the hospital;Patient satisfaction with the procedure (Five point Likert scale)Timepoint: Evaluated at 1 month following the procedure;Perception of operative difficulty by the trainee surgeons (three severity grades)Timepoint: During the procedure of laparoscopic cholecystectomy;Post operative pain scores (visual analogue scale)Timepoint: 06 hours, 12 hours, 24 hours, 1 week, 1 month;Proportion of patients having intra operative adverse events during Laparoscopic cholecystectomy (Injury to bile duct, bowel, right hepatic artery, gallbladder perforation)Timepoint: During the surgical procedure;Proportion of patients requiring to open procedureTimepoint: During the procedure of laparoscopic cholecystectomy	—

Measure

Time frame

Duration of postoperative hospitalisationTimepoint: Day of surgery will be counted as zero and calculated upto the day of discharge from the hospital;Patient satisfaction with the procedure (Five point Likert scale)Timepoint: Evaluated at 1 month following the procedure;Perception of operative difficulty by the trainee surgeons (three severity grades)Timepoint: During the procedure of laparoscopic cholecystectomy;Post operative pain scores (visual analogue scale)Timepoint: 06 hours, 12 hours, 24 hours, 1 week, 1 month;Proportion of patients having intra operative adverse events during Laparoscopic cholecystectomy (Injury to bile duct, bowel, right hepatic artery, gallbladder perforation)Timepoint: During the surgical procedure;Proportion of patients requiring to open procedureTimepoint: During the procedure of laparoscopic cholecystectomy

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Countries

India

Contacts

Public ContactDr Debajyoti Mohanty

AIIMS, Raipur

shreyamalhotra96@gmail.com

Outcome results

None listed

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