Double-blind randomised controlled trial of low pressure vs standard pressure in keyhole surgery for the gallbladder: a study to reduce pain following surgery

This study aims to answer the question whether it is beneficial to perform laparoscopy at low intra-abdominal pressure in a laparoscopic cholecystectomy operation (keyhole surgery to remove the gallbladder). The two primary objectives of the study are to establish the level of post-operative pain experienced by the patient through both a Likert post-operative pain score and totalling the quantity of opiate analgesia used, and to ensure that there is no compromise to the safety under which the operation is performed. This will be a double blinded randomised controlled trial with both surgeon and patient blinded to the intra-abdominal pressure used. The intra-abdominal pressures will be randomised to either 8mmHg or 12mmHg. Intra-operative data will be collected in real time (through direct observation by a study investigator including monitoring fidelity to the intervention), and protocols have been designed to protect patient safety in the event that surgeons feel the intra-abdominal view is compromised, which include the ability of the surgeon to increase intra-abdominal pressure to improve the view if required and a limit on pressure increases before the pressure becomes unblinded to all clinicians.