Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adrenalectomy
• Intervention / Treatment: Procedure: laparoscopic transabdominal adrenalectomy; Procedure: robotic transabdominal adrenalectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Parianos; Phone Number: 216 210-7832; Email: debsa@ccf.org
• Study Contact Backup: Name: Kimberly Jenkins; Phone Number: 216 445-4791; Email: jenkink@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • The Cleveland Clinic Foundation
      • Contact: Kimberly Jenkins; Phone Number: 216-445-4791; Email: jenkink@ccf.org
      • Contact: Andrea Parianos; Phone Number: 216 210-7832; Email: debsa@ccf.org
      • Principal Investigator: Eren Berber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Requirement for an open adrenalectomy based on imaging studies suggesting an aggressive cancer.
2. The presence of extensive surgical history precluding a minimally invasive approach to be undertaken.
3. Patients planned for a partial, rather than a complete adrenalectomy, as the former is a much easier procedure.
4. 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).
5. Mental incapacity or language barrier
6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 27 patients assigned to laparoscopic transabdominal adrenalectomy	Procedure: laparoscopic transabdominal adrenalectomy; Adrenalectomy performed by laparoscopic approach
Active Comparator: 27 patients assigned to robotic transabdominal adrenalectomy	Procedure: robotic transabdominal adrenalectomy; Adrenalectomy performed by robotic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin-to-skin operative time	The duration of the procedure measured in hours and/or minutes	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to robotic or laparoscopic approach	The number of patients who are required to convert to either a robotic or laparoscopic approach - a departure from what they were randomized to.	1 day
Postoperative pain scores (according to visual assessment score 0-10, with 0 being non pain and 10 being worst pain)	Post operative patient pain ratings on a scale of 0 - 10	1 day
Hospital stay	Length of hospital stay as measured in days	3 days
Cost	Reported as disposable/reusable median cost ratio and operating room time-cost ratio.	1 day

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Eren Berber, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be analyzed internally and a manuscript will be prepared. Data is not planned to be shared with outside or other investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No