Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

NCT01959711 | Completed Phase 4 DMC

• 1 other identifier: BBN 501/ZKL/130/L
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Tumor; Pheochromocytoma; Conn's Syndrome; Cushing's Syndrome

Keywords

Lateral transperitoneal laparoscopic adrenalectomy; Posterior retroperitoneoscopic adrenalectomy

Outcome Measures

Primary Outcomes (1)

• duration of surgery

  intraoperatively

Secondary Outcomes (3)

• postoperative recovery

  participants will be followed for the duration of hospital stay, an expected average of 7 days

• 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

Study Arms (2)

Posterior RA

EXPERIMENTAL

Posterior retroperitoneoscopic adrenalectomy

Procedure: Posterior RA

Lateral transperitoneal LA

ACTIVE COMPARATOR

Lateral transperitoneal laparoscopic adrenalectomy

Procedure: Lateral transperitoneal LA

Interventions

Posterior RA PROCEDURE

Posterior retroperitoneoscopic adrenalectomy

Posterior RA

Lateral transperitoneal LA PROCEDURE

Lateral transperitoneal laparoscopic adrenalectomy

Lateral transperitoneal LA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral adrenal tumor below 7cm in diameter without suspicion for malignancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University, Medical College, Third Chair of General Surgery

Krakow, 31-202, Poland

Location

Related Publications (7)

• 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.

  PMID: 17180554 BACKGROUND

• 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.

  PMID: 22526902 BACKGROUND

• 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.

  PMID: 18936580 BACKGROUND

• 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.

  PMID: 17188142 BACKGROUND

• 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.

  PMID: 23023976 BACKGROUND

• 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.

  PMID: 16006861 BACKGROUND

• 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.

  PMID: 25243546 DERIVED

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Pheochromocytoma; Hyperaldosteronism; Cushing Syndrome

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adrenocortical Hyperfunction

Study Officials

• Marcin Barczyński, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery at the Third Chair of General Surgery

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: October 10, 2013
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2013
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

PL (1)