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NCT Number: NCT06407024

Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy

This study is being done to compare Laparoscopic vs Robotic lateral transabdominal adrenalectomy, these procedures are both standard of care.

The study team would like to compare both patient outcomes and surgeon efficiency and perspectives among both procedures.

The information from this study will help improve patient care, patient outcomes and maximize the appropriate utilization of resources in adrenal surgery.

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Adrenalectomy used to be done through big open chevron, subcostal or thoraco-abdominal incisions that led to significant recovery and morbidity. In 1990s, the description of laparoscopic adrenalectomy revolutionized the care of these patients by converting the procedure into a minimally invasive operation with a short hospital stay and recovery. Since then, many centers have reported the safety and efficacy of laparoscopic adrenalectomy. Laparoscopic surgery uses rigid, straight instruments operated by the surgeons under the visual guidance of a two-dimensional video platform.

In the late 2000s, robotic systems have been developed that incorporated articulating wristed instruments used with a three-dimensional computerized video platform. Over the past two decades, robotic systems have penetrated many thoracic, cardiac and abdominal procedures.

A review of the National inpatient database in 2016 showed that 32.7% of the adrenalectomies in the US are being done robotically and 48.5% laparoscopically. Nevertheless, there are scant comparative data and only two randomized studies comparing laparoscopic with robotic adrenalectomy, one of which suffers from a small sample size (10 patients in each group Morino et al Surg Endosci) and the other from exclusion of tumor types (pheochromocytoma only Ma W et al Eur J Surg Oncol). The first study found laparoscopic approach to be superior and the latter study robotic approach to be more advantageous. Both studies highlighted the cost of robotic surgery to be a disadvantage versus laparoscopic approach. Underscoring the lack of data to recommend one technique versus the other, a meta-analysis concluded that robotic adrenalectomy is a safe and feasible procedure with similar clinical outcomes as the laparoscopic approach and recommended high quality randomized clinical trials to determine whether laparoscopic vs robotic approach was superior to perform adrenalectomy.

The study team's clinic has a high-volume minimally invasive adrenalectomy program with a good mixture of laparoscopic and robotic surgical expertise, performing close to 100 surgical cases a year. There are a number of barriers to performing the randomized studies required for adrenalectomy. The first one is the adrenal surgery volume. An average general surgeon does one adrenal surgery a year. A high-volume adrenal surgeon is considered to do > 4-6 adrenalectomies a year. Furthermore, there are only a few centers in the world that possesses a large both laparoscopic and robotic adrenalectomy experience. Being a unique adrenal surgery center, the study team believes that their center is one of the few centers in the world qualified to perform a randomized clinical trial comparing laparoscopic with robotic adrenalectomy. The study team believes that such a study will help understand whether one approach is more advantageous over the other regarding surgical outcomes, especially with the increasing use of robotics in surgical procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women between ages 18 and 75
  • Diagnosis of an adrenal tumor/pathology planned for a minimally invasive adrenalectomy at the department of endocrine surgery at the Cleveland Clinic.

Exclusion criteria

  • Requirement for an open adrenalectomy based on imaging studies suggesting an aggressive cancer.
  • The presence of extensive surgical history precluding a minimally invasive approach to be undertaken.
  • Patients planned for a partial, rather than a complete adrenalectomy, as the former is a much easier procedure.
  • Patients planned for a posterior adrenalectomy (these would be patients with an extensive surgical history with significant intra-abdominal adhesions and those requiring bilateral adrenalectomy).
  • Mental incapacity or language barrier
  • Any condition, unwillingness, or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol

Treatment and study plan

laparoscopic transabdominal adrenalectomy

Procedure

Adrenalectomy performed by laparoscopic approach

robotic transabdominal adrenalectomy

Procedure

Adrenalectomy performed by robotic approach

Primary outcomes

  1. Skin-to-skin operative time

    Time frame: 1 day

    The duration of the procedure measured in hours and/or minutes

Secondary outcomes

  1. Conversion to robotic or laparoscopic approach

    Time frame: 1 day

    The number of patients who are required to convert to either a robotic or laparoscopic approach - a departure from what they were randomized to.

  2. Postoperative pain scores (according to visual assessment score 0-10, with 0 being non pain and 10 being worst pain)

    Time frame: 1 day

    Post operative patient pain ratings on a scale of 0 - 10

  3. Hospital stay

    Time frame: 3 days

    Length of hospital stay as measured in days

  4. Cost

    Time frame: 1 day

    Reported as disposable/reusable median cost ratio and operating room time-cost ratio.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Parianos

CONTACT

[email protected]

216 210-7832

Kimberly Jenkins

CONTACT

[email protected]

216 445-4791

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy: a Single-center Randomized Prospective Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 9, 2024
Registry last updated
Feb 2, 2026

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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