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Completed

NCT Number: NCT01959711

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior RA

Procedure

Posterior retroperitoneoscopic adrenalectomy

Lateral transperitoneal LA

Procedure

Lateral transperitoneal laparoscopic adrenalectomy

Primary outcomes

  1. duration of surgery

    Time frame: intraoperatively

Secondary outcomes

  1. 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

  2. blood loss

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

  3. 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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up

Important dates

Study start
2006
Primary completion
2008
Study completion
2013
First posted
Oct 10, 2013
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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