Adrenocortical Hyperfunction
Conditions
Interventions
This is a randomized, parallel, single-blind clinical trial. Experimental group: 09 patients with adrenal tumors with indication for retroperitoneal adrenalectomy through dissection of the surgical sp
Sponsors
Hospital Nossa Senhora da Conceição
Hospital Militar de Área de Porto Alegre
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 or over; male and female; with adrenal tumors with indication for surgical removal after functional and imaging analysis; treated at the Clinical and Surgical Endocrinology outpatient clinic of Hospital Nossa Senhora da Conceição in Porto Alegre; and discussed in a monthly multidisciplinary Tumor Board meeting
Exclusion criteria
Exclusion criteria: Patients with a Body Mass Index (BMI) greater than 35; patients with a history of pyelonephritis ipsilateral to the adrenal tumor; tumors larger than 6 cm; tumors smaller than 4 cm and non-hypersecretory; tumors with invasion of adjacent structures (vena cava, kidney, duodenum) suggestive of adrenal carcinoma on imaging (Computed Tomography); patients with previous retroperitoneal surgery ipsilateral to the adrenal tumor or history of trauma; patients with contraindications or high risk for general anesthesia; malfunction of the Sonicision ultrasonic coagulator forceps in which it cannot be replaced or is not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: We expect to find a shorter surgical time required for identification of the upper renal pole during dissection of the retroperitoneal space in posterior video-assisted adrenalectomy using the balloon trocar (BTr) compared to telescopic dissection (TLC), by counting time with a stopwatch from the moment the laparoscope accesses the abdominal cavity. This will result in a reduction from 12.7 min (TLC group) to 8.6 min (BTr group) – mean 6.4 min + 2.2 min [+1 SD] – with a 95% chance of detection and a significance level of 5%;Outcome 1: There was no statistically significant difference between the groups: in the BTr group the mean time (interquartile median) was 31 minutes (23-49.5) and in the TLC group it was 21 minutes (13-33.5), with a p-value=0.19 | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 2: No statistically significant differences (considering a p-value less than 5% for significance) are expected between the two groups (non-superiority) in the following continuous quantitative variables: 1) Surgical Times, measured with a stopwatch: Total surgical time, from skin incision to specimen removal; T2 time, from skin incision to adrenal vein ligation. 2) Data measured by the insufflator device of the laparoscopy cart: Total CO2 volume used (in liters). 3) Capnography measured by the sensor attached to the orotracheal tube (carbon dioxide at end-expiration in mmHg, EtCO2): patient's carbon dioxide absorption during the specified moments of the Surgical Time;Outcome 2: There was no statistically significant difference (confirmed non-superiority) in the following outcomes: Total surgical time (p=0.60); T2 time (p=0.54); and patient CO2 uptake (0.54). The telescopic group (TLC) was superior in the outcome Total volume of CO2 used, as the balloon trocar group (BTr) used an average of 55.33% more: in the TrB group, the volume of carbon dioxide used (interquartile median) was 353 liters (273.5-501.5) and in the TLC group, it was 200 liters (110-233), with a p-value=0.01 ;Expected Outcome 3: No statistically significant differences (considering a p-value less than 5% for significance) are expected between the two groups (homogeneity is expected) in the following dichotomous quantitative variables: 1) need for conversion to another access technique (positive or negative event); 2) equipment failures (total number of complications). In the 30-day postoperative period, the anatomopathological result (disease diagnosis), length of hospital stay (in days; hospitalization after midnight is equivalent to one day of hospitalization), and postoperative pain (using a visual analog pain scale from 1 to 10) will be recorded. Surgical complications will be specified and measured using the Clavien-Dindo classification (scale from zero to 5), in addition to re | — |
Countries
Brazil
Contacts
Public ContactJosé Olijnyk
Hospital Nossa Senhora da Conceição
Outcome results
None listed