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Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

Primary Purpose

Adrenal Tumor, Pheochromocytoma, Conn's Syndrome

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Posterior RA
Lateral transperitoneal LA
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Tumor focused on measuring Lateral transperitoneal laparoscopic adrenalectomy, Posterior retroperitoneoscopic adrenalectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jagiellonian University, Medical College, Third Chair of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Posterior RA

Lateral transperitoneal LA

Arm Description

Posterior retroperitoneoscopic adrenalectomy

Lateral transperitoneal laparoscopic adrenalectomy

Outcomes

Primary Outcome Measures

duration of surgery

Secondary Outcome Measures

postoperative recovery
including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation
blood loss
postoperative complications
including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation

Full Information

First Posted
October 6, 2013
Last Updated
October 8, 2013
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT01959711
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumor, Pheochromocytoma, Conn's Syndrome, Cushing's Syndrome
Keywords
Lateral transperitoneal laparoscopic adrenalectomy, Posterior retroperitoneoscopic adrenalectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior RA
Arm Type
Experimental
Arm Description
Posterior retroperitoneoscopic adrenalectomy
Arm Title
Lateral transperitoneal LA
Arm Type
Active Comparator
Arm Description
Lateral transperitoneal laparoscopic adrenalectomy
Intervention Type
Procedure
Intervention Name(s)
Posterior RA
Intervention Description
Posterior retroperitoneoscopic adrenalectomy
Intervention Type
Procedure
Intervention Name(s)
Lateral transperitoneal LA
Intervention Description
Lateral transperitoneal laparoscopic adrenalectomy
Primary Outcome Measure Information:
Title
duration of surgery
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
postoperative recovery
Description
including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
blood loss
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
postoperative complications
Description
including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation
Time Frame
up to 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Barczyński, MD, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian University, Medical College, Third Chair of General Surgery
City
Kraków
ZIP/Postal Code
31-202
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17180554
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.
Results Reference
background
PubMed Identifier
22526902
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.
Results Reference
background
PubMed Identifier
18936580
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.
Results Reference
background
PubMed Identifier
17188142
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.
Results Reference
background
PubMed Identifier
23023976
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.
Results Reference
background
PubMed Identifier
16006861
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.
Results Reference
background
PubMed Identifier
25243546
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.
Results Reference
derived

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Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

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