Incisional hernia, Hernia, Herniorrhaphy,
Conditions
Interventions
Surgical techniques and surgeons
Two experienced surgeons (who previously performed over 50 minimal invasive hernia repairs) performed the allocated interventions, laparoscopic (LVIHR) or robotic (RVI
E04.680.325
E04.502.250.520
Sponsors
Faculdade de Medicina da Universidade de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (18-65 years) with any abdominal or pelvic incisional hernia following oncologic surgery
Exclusion criteria
Exclusion criteria: Patients that were pregnant, were under systemic chemotherapy, or presented any contraindication to general anesthesia or laparoscopy intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Presentation of expected outcome 1: Increased number of relapses within 24 months. Presentation of the method used to verify the expected outcome: verified using the Computed Tomography method. Presentation of the parameters used to verify whether the outcome actually occurs (numbers, percentages, rates, etc.): based on the finding (absolute number) of recurrence in the imaging method in the post-intervention evaluation. The difference between groups was assessed by Fisher's exact test. Outcome found 1: No difference was observed in relation to the long-term result. Recurrence was observed in 3 patients in the laparoscopic group (15.75%) and 2 in the robotic group (11.1%) at 24 months of follow-up (p>0.99). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 2: Presentation of expected outcome 2: Length of stay in the operating room. Presentation of the method used to verify the expected outcome: verified through the method counting the time in minutes that the patient arrives and leaves the operating room. Presentation of the parameters used to verify whether the outcome actually occurs (numbers, percentages, rates, etc.): counting the time in minutes that the patient arrives and leaves the operating room. The difference between groups was assessed by Student's t test. Outcome found 2: The average length of stay in the operating room for robotic surgery was significantly longer than for laparoscopic surgery (Robotics was 355.6 versus 293.5 minutes for laparoscopic surgery; p = 0.04).;Outcome 3 Presentation of expected outcome 3: Rate of operative complications. Presentation of the method used to verify the expected outcome: Patients were evaluated with clinical examination. Presentation of the parameters used to verify whether the outcome actually occurs (numbers, percentages, rates, etc.): based on the observation (percentage) of events (complications) in the post-intervention evaluation. The difference between groups was assessed by Fisher's exact test. Outcome found 3: No difference was observed for postoperative complications (for robotic surgery it was 16.7 versus 10.5%; p = 0.94).;Desfecho 4: Apresentação do desfecho esperado 4: Qualidade de vida em 24 meses após cirurgia. Apresentação do método usado para verificar o desfecho esperado: verificado por meio do método escore de EORTC QLQ-C30 [20. Christoffersen MW, Rosenberg J, Jorgensen LN, Bytzer P, Bisgaard T. Os escores de qualidade de vida relacionados à saúde mudam significativamente nos primeiros três meses após o reparo da tela de hérnia. World J Surg. Julho de 2014; 38 (7): 1852-9.] Apresentação dos parâmetros utilizados para verificar se o desfecho realmente ocorre (números, percentuais, índices etc.): média e desvio padrão da | — |
Countries
Brazil
Contacts
Public ContactFRANCISCO TUSTUMI
Outcome results
None listed