Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcin Barczynski, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01959711
First received: October 6, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Adrenal Tumor
Pheochromocytoma
Conn's Syndrome
Cushing's Syndrome
Procedure: Posterior RA
Procedure: Lateral transperitoneal LA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • duration of surgery [ Time Frame: intraoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative recovery [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: Yes ]
    including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation

  • blood loss [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: Yes ]
  • postoperative complications [ Time Frame: up to 5 years after surgery ] [ Designated as safety issue: Yes ]
    including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation


Enrollment: 65
Study Start Date: January 2006
Study Completion Date: July 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posterior RA
Posterior retroperitoneoscopic adrenalectomy
Procedure: Posterior RA
Posterior retroperitoneoscopic adrenalectomy
Active Comparator: Lateral transperitoneal LA
Lateral transperitoneal laparoscopic adrenalectomy
Procedure: Lateral transperitoneal LA
Lateral transperitoneal laparoscopic adrenalectomy

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959711

Locations
Poland
Jagiellonian University, Medical College, Third Chair of General Surgery
Kraków, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Marcin Barczyński, MD, PhD Jagiellonian University Medical College
  More Information

Publications:

Responsible Party: Marcin Barczynski, Associate Professor of Surgery at the Third Chair of General Surgery, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01959711     History of Changes
Other Study ID Numbers: BBN 501/ZKL/130/L
Study First Received: October 6, 2013
Last Updated: October 8, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
Lateral transperitoneal laparoscopic adrenalectomy
Posterior retroperitoneoscopic adrenalectomy

Additional relevant MeSH terms:
Syndrome
Pheochromocytoma
Cushing Syndrome
Adrenal Gland Neoplasms
Disease
Pathologic Processes
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 19, 2014