Clinical Trial: Accelerated Recovery Protocol in Patients Undergoing Bariatric Surgery

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: 38836 Patients will be randomly allocated into 3 different groups through a specific program for randomization of samples, respecting the 1:1:1 ratio, with 40 individuals in each group: Traditional Recovery Acceleration Protocol (PART); Early recovery protocol called Santa Marcelina Recovery Program (PROSM), with multimodal anesthesia, early physical therapy, abbreviation of pre and postoperative fasting, in addition to the application of long‐term local anesthesia called Preemptive Target anesthetic solution (PTAS); and the third group with the PROSM protocol, but with PTAS‐placebo, consisting of a saline solution with 20 ml of 8.4% sodium bicarbonate. CONDITION: unspecified obesity PRIMARY OUTCOME: Expected Outcome: Impact of the intervention on the length of stay, assessed through data from the medical record, with an expected decrease of 25% in the length of stay in the hospital, measured in hours. SECONDARY OUTCOME: Expected Outcome 1: Impact of the intervention on postoperative analgesia, measured using a visual scale. Expected outcome 3: possible changes in complication rates, as measured by the Clavien‐Dindo (CD) classification, in the first 90 days after surgery. These will be separated into minor (CD I ‐ II) and major (CD III ‐ V) in order to refine the analysis. Expected outcome 2: possible change in the incidence rate of postoperative nausea and vomiting events, measured by the postoperative nausea and vomiting scale, during the hospitalization period Expected outcome 5: assessment of the rate of the number of times the patient is readmitted compared to the number of patients operated on, in the first 90 days after surgery Expected Outcome 7: Assessment of subjective patient satisfaction using a decimal scale within the first ninety days, measured at 2 moments, at discharge and 90 days after surgery Expected outcome 4: assessment of the rate of the number of times the patient returns to the emergency room compared to the number of patients operated on, in the first 90 days after surgery Expected outcome 6: assessment of the rate of the number of times the patient is reoperated compared to the number of patients operated on, in the first 90 days after surgery INCLUSION CRITERIA: Patients aged between 18 and 60 years; able to read, understand and sign the consent form; undergoing the first procedure for the treatment of obesity
Epistemonikos ID: cdd9bbbbe9bfbd358303b5a29f5e71704fecdc28
First added on: Aug 25, 2024