Clinical trial NCT01959711: Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy
Official title: Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenal Tumor
Pheochromocytoma
Conn's Syndrome
Cushing's Syndrome
Keywords: Lateral transperitoneal laparoscopic adrenalectomy
Posterior retroperitoneoscopic adrenalectomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of surgery
timeFrame: intraoperatively
Secondary outcomes:
measure: postoperative recovery
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: blood loss
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: postoperative complications
timeFrame: up to 5 years after surgery
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University, Medical College, Third Chair of General Surgery
Study officials:
affiliation: Jagiellonian University
name: Marcin Barczyński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barczynski M, Konturek A, Golkowski F, Cichon S, Huszno B, Peitgen K, Walz MK. Posterior retroperitoneoscopic adrenalectomy: a comparison between the initial experience in the invention phase and introductory phase of the new surgical technique. World J Surg. 2007 Jan;31(1):65-71. doi: 10.1007/s00268-006-0083-8.
citation: Lee CR, Walz MK, Park S, Park JH, Jeong JS, Lee SH, Kang SW, Jeong JJ, Nam KH, Chung WY, Park CS. A comparative study of the transperitoneal and posterior retroperitoneal approaches for laparoscopic adrenalectomy for adrenal tumors. Ann Surg Oncol. 2012 Aug;19(8):2629-34. doi: 10.1245/s10434-012-2352-0. Epub 2012 Apr 20.
citation: Perrier ND, Kennamer DL, Bao R, Jimenez C, Grubbs EG, Lee JE, Evans DB. Posterior retroperitoneoscopic adrenalectomy: preferred technique for removal of benign tumors and isolated metastases. Ann Surg. 2008 Oct;248(4):666-74. doi: 10.1097/SLA.0b013e31818a1d2a.
citation: Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50. doi: 10.1016/j.surg.2006.07.039.
citation: Constantinides VA, Christakis I, Touska P, Palazzo FF. Systematic review and meta-analysis of retroperitoneoscopic versus laparoscopic adrenalectomy. Br J Surg. 2012 Dec;99(12):1639-48. doi: 10.1002/bjs.8921. Epub 2012 Sep 28.
citation: Rubinstein M, Gill IS, Aron M, Kilciler M, Meraney AM, Finelli A, Moinzadeh A, Ukimura O, Desai MM, Kaouk J, Bravo E. Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy. J Urol. 2005 Aug;174(2):442-5; discussion 445. doi: 10.1097/01.ju.0000165336.44836.2d.
citation: Barczynski M, Konturek A, Nowak W. Randomized clinical trial of posterior retroperitoneoscopic adrenalectomy versus lateral transperitoneal laparoscopic adrenalectomy with a 5-year follow-up. Ann Surg. 2014 Nov;260(5):740-7; discussion 747-8. doi: 10.1097/SLA.0000000000000982.