unspecified obesity
Conditions
Interventions
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
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 applicati
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.
38836
Sponsors
Casa de Saúde Santa Marcelina
Casa de Saúde Santa Marcelina
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: patients with a BMI above 60 kg/m2; patients with chronic pain with continuous use of medications for pain control, such as fibromyalgia and non-eventual low back pain; patients with heart and coronary diseases; ventricular ejection fraction less than 50%; anticoagulation with warfarin; patients with chronic kidney disease on dialysis; patients with mobility and ambulation difficulties; prolonged surgical time (greater than 3 hours) or need for conversion to open surgery; patients referred to the intensive care unit (ICU) after the procedure; need for drainage of the abdominal cavity; latex allergy; allergy to any of the medications used in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Impact of the intervention on postoperative analgesia, measured using a visual scale.;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 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 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 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 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;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 | — |
Countries
Brazil
Contacts
Public ContactMarcos Gouveia de Oliveira
Casa de Saúde Santa Marcelina
Outcome results
None listed