Data Collection for Patient Safety in Lap Cholecystectomy version 1.0

• Research type

  Research Study

• Full title

  Data Collection for Artificial Intelligence Development Aimed at Increasing Intraoperative Patient Safety During Laparoscopic Cholecystectomy

• IRAS ID

  355639

• Contact name

  Matthew Clarkson

• Contact email

  m.clarkson@ucl.ac.uk

• Sponsor organisation

  UCL Joint Research Office

• Clinicaltrials.gov Identifier

  182993, Edge; Z6364106/2025/11/11 health research, UCL Data Protection Office: Data protection number

• Duration of Study in the UK

  2 years, 11 months, 1 days

• Research summary

  This study focuses on data collection related to patients undergoing Laparoscopic Cholecystectomy (Lap Chole) – removal of the gallbladder through minimally invasive approach. The collected data will be used for the development of a range of artificial intelligence (AI) models focusing on improving patient safety.

  AI has shown a significant promise in improving diagnosis, intraoperative guidance and prevention of life altering surgical complications. With over 60 000 annually performed LC in the UK, even a relatively low incidence rate of surgical error can affect substantial number of patients leaving them with life changing outcomes. Currently, the main challenge faced by the AI engineers is lack of sufficient, high-quality data necessary to create the models. Data acquired through this study, will facilitate innovation in several areas related to the development of medical AI, with example applications being: Case Difficulty Stratification, Augmented Reality Overlays, Intraoperative Surgical Guidance, Surgical Training.

  This study will involve recording of the laparoscopic camera view during the operation and a collection of associated, anonymised, patient data, specifically: age, sex, BMI, count of white blood cells measured prior to surgery, history of prior abdominal surgery (related to gallbladder/bile ducts/liver), history of prior ERCP as well as any retrospectively available preoperative images from MRCP, MRI, CT, X-Ray/ERCP. The study will not require any alterations to the standard operating procedure. The video recordings will be acquired intraoperatively, by one of the investigators, who will press a record button on a device attached to the laparoscope stack after the patient has been anesthetised and the camera inserted into the participant.

  The study aims at collecting the following data:
  Each participant

  General information
  Age
  Gender
  BMI
  Condition requiring laparoscopic cholecystectomy
  Type of surgery: elective, acute
  Count of white blood cells prior to the surgery
  ASA Score
  Diabetes
  Hypertension
  Alanine transaminase (IU/L)
  Triglycerides (mmol/L)
  CRP (mg/L)
  Preoperative imaging reports related to the laparoscopic cholecystectomy
  History of prior abdominal surgery related to gallbladder/bile ducts/liver
  History of prior Endoscopic Retrograde Cholangiopancreatography (ERCP)

  Recording of the laparoscopic camera view during the laparoscopic cholecystectomy procedure

  Where available
  Preoperative scans (only related to lap chole procedure)
  MRCP
  MRI
  CT
  Ultrasound
  X-Ray / ERCP"

• REC name

  London - Central Research Ethics Committee

• REC reference

  26/LO/0197

• Date of REC Opinion

  7 Apr 2026

• REC opinion

  Further Information Favourable Opinion