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Adrenal TumorPhase 4NCT01959711

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

A Phase 4 study testing Posterior RA and Lateral transperitoneal LA in people with Adrenal Tumor and Pheochromocytoma, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adrenal Tumor, Pheochromocytoma, Conn's Syndrome
What is being tested?
Posterior RA and Lateral transperitoneal LA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 sitePoland
Study dates
Jan 2006to Jul 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Krakow, 31-202

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Posterior RA, Lateral transperitoneal LA
Keywords
Lateral transperitoneal laparoscopic adrenalectomy, Posterior retroperitoneoscopic adrenalectomy
Medical subject headings
Adrenal Gland Neoplasms, Pheochromocytoma, Hyperaldosteronism, Cushing Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posterior RAProcedure or surgery

    Posterior retroperitoneoscopic adrenalectomy

  • Lateral transperitoneal LAProcedure or surgery

    Lateral transperitoneal laparoscopic adrenalectomy

Study groups in NCT01959711
Study groupRoleWhat they receive
Posterior RAExperimentalPosterior retroperitoneoscopic adrenalectomy
Receives: Procedure: Posterior RA
Lateral transperitoneal LAActive comparatorLateral transperitoneal laparoscopic adrenalectomy
Receives: Procedure: Lateral transperitoneal LA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of surgery

    Measured: intraoperatively

Secondary outcomes (3)

  1. postoperative recovery

    including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation

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

  2. blood loss

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

  3. postoperative complications

    including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation

    Measured: up to 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2008
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959711
Sponsor's protocol ID
BBN 501/ZKL/130/L
Status last verified
Oct 2013
First submitted
6 Oct 2013
Last updated
10 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17180554

  • 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.

    PubMed 22526902

  • 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.

    PubMed 18936580

  • 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.

    PubMed 17188142

  • 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.

    PubMed 23023976

  • 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.

    PubMed 16006861

  • 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.

    PubMed 25243546

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Posterior RA and Lateral transperitoneal LA in people with Adrenal Tumor and Pheochromocytoma, run by Jagiellonian University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

duration of surgery (time frame: intraoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959711, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.

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