Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

Phase 4

Completed

• Conditions: Pheochromocytoma; Adrenal Tumor; Conn's Syndrome; Cushing's Syndrome
• Interventions: Procedure: Posterior RA; Procedure: Lateral transperitoneal LA

• Registration Number: NCT01959711
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2013-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-06
• Study First Submitted QC: 2013-10-08
• Last Update Submitted: 2013-10-08
• Study First Posted: 2013-10-10
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior RA	Posterior RA	Posterior retroperitoneoscopic adrenalectomy
Lateral transperitoneal LA	Lateral transperitoneal LA	Lateral transperitoneal laparoscopic adrenalectomy

Primary Outcome Measures

Name	Time	Method
duration of surgery	intraoperatively

Secondary Outcome Measures

Name	Time	Method
postoperative recovery	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	participants will be followed for the duration of hospital stay, an expected average of 7 days
postoperative complications	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

Trial Locations

Locations (1)

Jagiellonian University, Medical College, Third Chair of General Surgery; 🇵🇱 Kraków, Poland