ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01959711
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):
Marcin Barczynski, Jagiellonian University

October 6, 2013
October 10, 2013
October 10, 2013
January 2006
June 2008   (Final data collection date for primary outcome measure)
duration of surgery [ Time Frame: intraoperatively ]
Same as current
No Changes Posted
  • postoperative recovery [ Time Frame: 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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ]
  • postoperative complications [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy
Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Adrenal Tumor
  • Pheochromocytoma
  • Conn's Syndrome
  • Cushing's Syndrome
  • Procedure: Posterior RA
    Posterior retroperitoneoscopic adrenalectomy
  • Procedure: Lateral transperitoneal LA
    Lateral transperitoneal laparoscopic adrenalectomy
  • Experimental: Posterior RA
    Posterior retroperitoneoscopic adrenalectomy
    Intervention: Procedure: Posterior RA
  • Active Comparator: Lateral transperitoneal LA
    Lateral transperitoneal laparoscopic adrenalectomy
    Intervention: Procedure: Lateral transperitoneal LA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
Same as current
July 2013
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01959711
BBN 501/ZKL/130/L
Yes
Not Provided
Not Provided
Marcin Barczynski, Jagiellonian University
Jagiellonian University
Not Provided
Principal Investigator: Marcin Barczyński, MD, PhD Jagiellonian University
Jagiellonian University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP