AdrenalectomyNCT06407024
Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy
A study testing laparoscopic transabdominal adrenalectomy and robotic transabdominal adrenalectomy in people with Adrenalectomy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adrenalectomy
- What is being tested?
- laparoscopic transabdominal adrenalectomy and robotic transabdominal adrenalectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Kimberly Jenkins, 216-445-4791, jenkink@ccf.org
Andrea Parianos, 216 210-7832, debsa@ccf.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Adrenalectomy
- Being tested
- laparoscopic transabdominal adrenalectomy, robotic transabdominal adrenalectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic transabdominal adrenalectomyProcedure or surgery
Adrenalectomy performed by laparoscopic approach
robotic transabdominal adrenalectomyProcedure or surgery
Adrenalectomy performed by robotic approach
| Study group | Role | What they receive |
|---|---|---|
| 27 patients assigned to laparoscopic transabdominal adrenalectomy | Active comparator | Not described Receives: Procedure: laparoscopic transabdominal adrenalectomy |
| 27 patients assigned to robotic transabdominal adrenalectomy | Active comparator | Not described Receives: Procedure: robotic transabdominal adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin-to-skin operative time
The duration of the procedure measured in hours and/or minutes
Measured: 1 day
Secondary outcomes (4)
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.
Measured: 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
Measured: 1 day
Hospital stay
Length of hospital stay as measured in days
Measured: 3 days
Cost
Reported as disposable/reusable median cost ratio and operating room time-cost ratio.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start22 May 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdrenalectomyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eren Berber, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407024
- Sponsor's protocol ID
- 23-422
- Status last verified
- Jan 2026
- First submitted
- 6 May 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed internally and a manuscript will be prepared. Data is not planned to be shared with outside or other investigators
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy: a Single-center Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT06407024
- Acronym / sponsor ID
- 23-422
- Conditions
- Adrenalectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 27 patients assigned to laparoscopic transabdominal adrenalectomy | Active comparator | Procedure: laparoscopic transabdominal adrenalectomy |
| 27 patients assigned to robotic transabdominal adrenalectomy | Active comparator | Procedure: robotic transabdominal adrenalectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic transabdominal adrenalectomyAdrenalectomy performed by laparoscopic approach | Procedure or surgery | 27 patients assigned to laparoscopic transabdominal adrenalectomy |
| robotic transabdominal adrenalectomyAdrenalectomy performed by robotic approach | Procedure or surgery | 27 patients assigned to robotic transabdominal adrenalectomy |
Primary outcome
Skin-to-skin operative time
Time frame: 1 day
The duration of the procedure measured in hours and/or minutes
4 secondary outcomes
Conversion to robotic or laparoscopic approach
Time frame: 1 day
Postoperative pain scores (according to visual assessment score 0-10, with 0 being non pain and 10 being worst pain)
Time frame: 1 day
Hospital stay
Time frame: 3 days
Cost
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Data will be analyzed internally and a manuscript will be prepared. Data is not planned to be shared with outside or other investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eren Berber, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic transabdominal adrenalectomy and robotic transabdominal adrenalectomy in people with Adrenalectomy, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Jenkins (216 445-4791, jenkink@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin-to-skin operative time (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.