Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Experimental group: 10 patients with adrenal tumors (05 right and 05 left) with indication for retroperitoneal adrenalectomy through dissection of the surgical space using the balloon trocar developed
Device
Sponsors
Hospital Nossa Senhora da Conceição
Hospital Nossa Senhora da Conceição
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients with adrenal tumors with indication for surgical removal after functional and image analysis, seen at the Clinical and Surgical Endocrinology outpatient clinic of Hospital Nossa Senhora da Conceição in Porto Alegre and discussed in a monthly multidisciplinary meeting Tumor Board.
Exclusion criteria
Exclusion criteria: Patients with BMI more than 35; patients with a history of pyelonephritis ipsilateral to the adrenal tumor; tumors greater than 6 cm; tumors with invasion of adjacent structures (vena cava, kidney, duodenum) suggestive of Adrenal carcinoma on Image examination (Tomography or Magnetic Resonance); patients with previous retroperitoneal surgery ipsilateral to the adrenal tumor or history of trauma; patients with contraindication or high risk for general anesthesia; Sonicision Ultrasonic Dissecting device (Covidien) malfunctioning in which it cannot be replaced or is not available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome of the study: The use of the Bhio Supply © balloon trocar for the dissection of the retroperitoneal space in posterior adrenalectomy (retroperitoneoscopic) reduces the total and partial surgical time, in relation to the dissection performed only with the use of laparoscopic optics. The continuous quantitative variable (Surgical time measured in minutes with a stopwatch) will be measured according to the progress of the surgery: Total time, measured from the skin incision until the removal of the specimen; T1 time, measured from the skin incision until identification of the upper pole of the kidney; T2 time, measured from the skin incision to the adrenal vein ligation. In addition, these results will be compared for the primary diagnosis of adrenal pathology, Body Mass Index and operated side (considering that 10 surgeries on the right and 10 surgeries on the left will be performed after randomization, with half of the sample on each side dissected by telescoping and half using balloon trocar). | — |
Secondary
| Measure | Time frame |
|---|---|
| The continuous quantitative variable of carbon dioxide use for the retroperitoneal space insufflation will be measured: gas pressure used (Initial Pressure; Final Pressure, in mmHg, shown in the insufflation device) and Total CO2 Volume used (in liters, also measured in insufflation device). The absorption of carbon dioxide by the patient during the specified moments of the Surgical Time will be assessed by capnography of the sensor adapted to the orotracheal tube (corbonic gas at the end of expiration in mmHg, EtCO2). For dichotomous quantitative variables (positive or negative event), it will be recorded: 1) need for conversion to another access technique; 2) instrumental complications with the use of the Balloon Trocar in the respective group 3) need to increase pressure beyond 20 mmHg; 3) instability of the operating field / gas leak; 4) bleeding that requires aspiration and the need for transfusion; 5) capsular rupture of the gland and complete removal of the specimen. In the 30-day postoperative period, the anatomopathological result will be recorded, the length of stay (in days; hospitalization of the patient beyond midnight is equivalent to 1 day of hospitalization) and postoperative pain (using a visual analogue pain scale 1 to 10). Surgical complications will be specified and measured using the Clavien-Dindo classification, in addition to recording the need to return to the emergency, rehospitalization, reintervention or death of the patient. | — |
Countries
Brazil
Contacts
Public ContactJosé Olijnyk
Hospital Nossa Senhora da Conceição
Outcome results
None listed