Randomisation, blinding and data flow
inflammation
INFLAMMATION, ACUTE CHOLECYSTITIS, ADHESIONS
A convenient sample of 100 participants was decided, divided into 50 for each study arm. The two study arms were colour coded. The colour codes were used for randomization, data entry and analysis. All the participants, investigators, operating surgeons, observers, and analyst were blinded to the colour code reference. After closure of the study, the colour codes were disclosed to the public. Allocation was random according to a pre-set computer-generated list. Patients found to have intra operative adhesions and evidence of previous inflammation were kept in the study, ensuring no previously documented diagnosis of acute cholecystitis.The principal investigator ensured adherence to protocol and data validity. Records were reviewed monthly, and a progress summary written and provided to study regulatory every three months. Some patients where administered dexamethasone intravenously at time of surgery induction by anaesthesia team, so subgroup analysis for dexamethasone was done to eliminate its effect on the study results.