Adrenal Tumor, Conn's Syndrome, Cushing's Syndrome, Pheochromocytoma
Conditions
Keywords
Lateral transperitoneal laparoscopic adrenalectomy, Posterior retroperitoneoscopic adrenalectomy
Brief summary
Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the LTLA as minimally invasive approach to small and benign adrenal tumors.
Detailed description
Laparoscopic adrenalectomy has replaced open adrenalectomy as the standard operation for non-malignant adrenal tumours. Thanks to the popularization of the posterior technique described by Walz and co-workers, the posterior retroperitoneal adrenalectomy (PRA) is being performed in increasing numbers worldwide. Advocates for the laparoscopic and retroperitoneoscopic approaches cite the advantages of each technique, but there is no published evidence that supports the superiority of one over the other. Most of the published literature is retrospective, with inadequate or no controls and with potential biases. The aim of this study is to test the hypothesis that PRA is superior to the lateral transperitoneal laparoscopic adrenalectomy (LTLA) as minimally invasive approach to small and benign adrenal tumors. For a sample size calculation an assumption was made that a 20% reduction in duration of surgery represents clinically relevant difference. To detect this, it was calculated that 24 patients would be required in each treatment arm to give the study a power of 90 per cent. Anticipating a 25% loss to follow-up, 32 patients per arm were required in the study.
Interventions
PROCEDUREPosterior RA
Posterior retroperitoneoscopic adrenalectomy
PROCEDURELateral transperitoneal LA
Lateral transperitoneal laparoscopic adrenalectomy
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* unilateral adrenal tumor below 7cm in diameter without suspicion for malignancy
Exclusion criteria
* active malignancy * pregnancy or lactation * age below 18 years, or above 80 years * high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher * inability to comply with the scheduled follow-up protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of surgery | intraoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative recovery | participants will be followed for the duration of hospital stay, an expected average of 7 days | including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation |
| blood loss | participants will be followed for the duration of hospital stay, an expected average of 7 days | — |
| postoperative complications | up to 5 years after surgery | including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation |
Countries
Poland
Outcome results
None listed