Esophageal Achalasia
Conditions
Interventions
Study design and participants: This study will be an open-label randomized controlled trial. Patients will be recruited from a public hospital (Hospital das Clínicas da Universidade de São Paulo, São
E04.210.390
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with achalasia; patients with indication for surgical treatment (with Eckardt =3); age between 18 and 65 years old; male and female sex
Exclusion criteria
Exclusion criteria: Patients who refused to participate in the study; pregnant patients; patients who have any contraindication to general anesthesia or laparoscopic intervention; morbid obesity (BMI>30 kg/m2); patients undergoing previous diaphragmatic hiatus surgeries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the success rate of surgery for each study group. Success will be defined as Eckardt <3 at 12 months of postoperative follow-up. The results will be presented in Absolute Risk Reduction.;Assess gastroesophageal reflux. For this, the reflux scale (GERD-HRQL (Gastroesophageal Reflux Disease - Health Related Quality of Life) will be used. The results will be presented in Absolute Mean Difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate operative complications (bleeding, inadvertent mucosal perforation during myotomy, inadvertent injury to the spleen or other organs). The results will be presented in Risk Difference.;Evaluate the postoperative hospital stay. It will be evaluated in days, from the moment of admission to the day of hospital discharge. The results will be presented in Absolute Mean Difference.;Assess pain during hospitalization, using the visual analogue pain score (0-10). The results will be presented in Absolute Mean Difference.;Evaluate surgical time, measured in minutes, from the time of the first surgical incision to skin synthesis. The results will be presented in Absolute Mean Difference.;Assess direct costs. The direct medical costs of treatment will be described from the institution's perspective. A mixed methodology of micro and macro-costing will be used. Estimates of daily costs related to hospitalization and surgery (operating room time, medical and multidisciplinary consultations, daily rates in wards, ICUs and outpatient consultations) will be evaluated by apportioning fixed and variable costs (human resources, material resources and infrastructure) evaluating the respective unit values of the costs of the institution's health services used. Medicines, medical devices, nutrition, blood, laboratory and imaging studies will be evaluated by calculating the microcost according to the patient's individual consumption multiplied by the respective acquisition cost. Operating room time will be measured from the patient's entry to the exit from the operating room, including anesthesia and surgery. Costs are presented in reais (R$). The results will be presented in Absolute Mean Difference. | — |
Countries
Brazil
Contacts
Public ContactFrancisco Tustumi
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed