METHODS
obesity, pulmonary or urinary infections, cancer, DVT, pain, infection, visual pain, psychiatric, fistula, venous thromboembolism, digestive hemorrhage
OBESITY, OBESE, DEEP VENOUS THROMBOSIS, CANCER, DISEASE, DIABETES MELLITUS TYPE 2, INFECTION, PULMONARY ATELECTASIS, SURGICAL COMPLICATIONS, COMPLICATIONS, DVT
This a randomized cohort study, approved by the Ethics Committee of the Pontifícia Universidade Católica do Paraná (number of 2.348.495). The period of study was 18 months.Eighty obese patients with indication of bariatric surgery were included, according to the following criteria: age between 18 and 55 years; BMI >35 and <50 kg/m² (obesity grade II or III); preoperative endocrinological, cardiological, surgical, nutritional and psychological or psychiatric evaluation; patients with diabetes mellitus type 2, less than 10 (ten) years of the disease; no previous upper abdominal surgery; without other serious morbidities, which may offer an increase in the anesthetic risk related to the laparoscopic procedure; possibility of clinical follow-up for 12 months; and signature of the Term of Free and Informed Consent after properly informed about risks and possible complications of the procedure by the health team.The exclusion criteria used were: surgical risk according to the American Society of Anesthesiologists (ASA) >2; pregnancy or lactation; any contraindication for the surgical treatment of obesity; presence of active infection; cancer in progression or any other chronic or acute progressive disease with a reserved prognosis.The patients were equally and randomly assigned in laparoscopic and laparotomy groups. After the procedure, the patients were followed up and evaluated during their hospital stay and ambulatory returns, according to the Ministry of Health protocol for postoperative of bariatric surgery.The order of the study was as follows: 1. Selection of morbidly obese patients according to inclusion criteria; 2. Application of a standardized questionnaire to participants; 3. Signature of informed consent; 4. Multi-professional consultation (endocrinologist, cardiologist, surgeon, and psychologist); 5. Performing preoperative exams; 6. Conduct of procedures; and 7. Postoperative follow-up for 12 months (return visits in 15- to 30-day, 2-month, 3-month, 4-month, 6-month, 9-month and 12-month periods). During the visits, routine clinical and laboratory parameters were evaluated, as well as endoscopic and imaging parameters, according to the specific indication and then, data analysis.The project was developed together with the Advanced Center of Videolaparoscopy of Paraná (CEVIP) and the Bariatric and Metabolic Surgery Service of the Santa Casa de Misericórdia Hospital in Curitiba (PR). The procedures were undertaken at the Santa Casa de Misericórdia Hospital in Curitiba (PR), which had infrastructure and experience in operations of high complexity.All the procedures were standardized between the two groups, differing only by the access route. After general anesthesia, intermittent pneumatic compression boots were installed for prophylaxis of deep venous thrombosis (DVT), as performed routinely in bariatric surgery.The randomization procedure was applied by means of a simple draw of sealed envelopes, without external identification, at the moment preceding the beginning of the operation.After the procedure, the length of hospital stay, analgesic use, total cost of hospitalization, visual pain scale, clinical complications (pulmonary or urinary infections, pulmonary atelectasis, venous thromboembolism) and surgical complications (digestive hemorrhage, fistula, abdominal wall) were evaluated and recorded.In the first postoperative day, it was performed: fasting maintenance, intravenous analgesia with simple analgesics and opioids; general clinical evaluation; and early motor and respiratory physiotherapy.As for the second postoperative day, the patients received: oral diet introduction, fractionally restricted liquid for both groups; general clinical evaluation; motor and respiratory physiotherapy; simple intravenous analgesics and opioids if needed; and hospital discharge at afternoon if good tolerance to pain and diet.For the third postoperative day, patients took: an oral diet, restricted and fractional liquid for both groups; general clinical evaluation; motor and respiratory physiotherapy; simple intravenous analgesics and opioids if needed; and hospital discharge in the morning if good tolerance to pain and diet.During outpatient follow-up, the patients were evaluated according to the routine established by the Ministry of Health protocol for postoperative bariatric surgery (Annex I), plus an additional evaluation at the end of the third postoperative month. All returns analyzed the occurrence of surgical and clinical complications, quality of life, and time of return to usual work activities.The data collected in this study were compiled into Microsoft Excel® tables, using Epi Info™ software for statistical analysis. The quantitative variables were described as mean, median, minimum and maximum values, and qualitative variables by frequencies and percentages. For the comparison of the groups, concerning qualitative variables, the Fisher’s exact test and the Pearson’s chi-square (χ²) tests were considered. Regarding quantitative variables, the groups were compared using Student’s 