Laparoscopic vs Robotic Surgery for Adrenalectomy

Overseen By Kimberly Jenkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Aggressive cancer, Extensive surgical history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of surgery for adrenal gland removal: laparoscopic (using small incisions and a camera) and robotic (using robotic arms controlled by a surgeon). The goal is to determine which method results in better patient outcomes and more efficient surgeries. Suitable candidates have an adrenal tumor and plan to undergo minimally invasive surgery at the Cleveland Clinic. The findings will guide doctors in selecting the best surgical method for adrenal gland removal. As an unphased trial, it allows patients to contribute to valuable research that could enhance surgical techniques and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these surgical techniques are safe for adrenalectomy?

Research has shown that both laparoscopic and robotic adrenalectomy are generally safe and effective. Laparoscopic adrenalectomy often results in fewer complications and quicker recovery compared to traditional open surgery. Complications occur in 0% to 15% of cases when operating on one adrenal gland and up to 23% when both glands are involved.

Robotic adrenalectomy is also considered safe. Some studies suggest it might shorten hospital stays and reduce blood loss compared to laparoscopic surgery. The need for a blood transfusion is low, occurring in less than 2% of cases. Overall, both methods are well-tolerated, with robotic surgery possibly offering additional convenience and safety benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing laparoscopic and robotic surgeries for adrenalectomy because these techniques offer minimally invasive options with potentially different advantages. Laparoscopic surgery is a well-established method known for reduced recovery times and smaller incisions compared to open surgery. However, robotic surgery takes this a step further by providing enhanced precision, flexibility, and control through advanced robotic systems, which could lead to even better outcomes and reduced complication rates. This trial aims to determine which approach delivers superior results, paving the way for more personalized and effective surgical care for adrenal gland conditions.

What evidence suggests that these surgical techniques are effective for adrenalectomy?

This trial will compare laparoscopic and robotic adrenalectomy for removing adrenal glands. Research has shown that laparoscopic adrenalectomy is safe and effective, offering benefits like less blood loss, fewer complications, and faster recovery compared to open surgery. It is particularly effective for removing large adrenal tumors. Robotic adrenalectomy also shows promise, providing precise surgery with less bleeding and potentially shorter hospital stays. Both methods yield similar overall results, but the robotic approach may be better for some patients. Each technique has its advantages, making them both viable options for adrenal surgery. Participants in this trial will undergo either laparoscopic or robotic adrenalectomy to further evaluate these methods. ^{3 6 7 8 9}

Who Is on the Research Team?

Eren Berber, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who require an adrenalectomy, a surgery to remove one or both adrenal glands. Participants should be suitable candidates for minimally invasive surgery but specific conditions that would exclude someone from participating are not listed.

Inclusion Criteria

I am diagnosed with an adrenal tumor and scheduled for a minimally invasive surgery at the Cleveland Clinic.

Exclusion Criteria

I am scheduled for a surgery to remove part of my adrenal gland.

I need surgery to remove my adrenal gland due to aggressive cancer.

I do not have any mental incapacity or language barriers that prevent understanding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either laparoscopic or robotic transabdominal adrenalectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative outcomes including pain scores and hospital stay

3 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic vs Robotic Lateral Transabdominal Adrenalectomy

Trial Overview The study compares two types of minimally invasive surgeries: laparoscopic and robotic lateral transabdominal adrenalectomy. It aims to evaluate patient outcomes and the efficiency and perspectives of surgeons using these methods.

How Is the Trial Designed?

Group I: 27 patients assigned to laparoscopic transabdominal adrenalectomy Active Control 1 Intervention

Group II: 27 patients assigned to robotic transabdominal adrenalectomy Active Control 1 Intervention

Laparoscopic vs Robotic Lateral Transabdominal Adrenalectomy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Laparoscopic Adrenalectomy for:

• Adrenal tumors
• Hyperaldosteronism
• Cushing's syndrome
• Pheochromocytoma

Approved in United States as Robotic Adrenalectomy for:

• Adrenal tumors
• Hyperaldosteronism
• Cushing's syndrome
• Pheochromocytoma

Approved in Canada as Minimally Invasive Adrenalectomy for:

• Adrenal tumors
• Hyperaldosteronism
• Cushing's syndrome
• Pheochromocytoma

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study comparing robotic and laparoscopic adrenalectomy for tumors larger than 5 cm, robotic surgery resulted in shorter operative times (159.4 minutes vs. 187.2 minutes) and a lower conversion rate to open surgery (4% vs. 11%).

The robotic approach also led to a shorter hospital stay (1.4 days vs. 1.9 days) and had no 30-day morbidity, while the laparoscopic group had a 2.7% morbidity rate, suggesting that robotic adrenalectomy is a safer and more efficient option for large adrenal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus laparoscopic resection of large adrenal tumors. Agcaoglu, O., Aliyev, S., Karabulut, K., et al.[2012]

Laparoscopic posterior retroperitoneal adrenalectomy (PRA) is more effective than laparoscopic lateral transperitoneal adrenalectomy (LTA) in terms of shorter operation times and reduced hospital stays, based on a systematic review of eight studies.

Robotic adrenalectomy does not show superior outcomes compared to laparoscopic adrenalectomy, indicating that while both methods are effective, further advancements and cost reductions are necessary for robotic techniques to be more widely adopted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Surgical Approaches for Adrenal Tumors: Lateral Transperitoneal versus Posterior Retroperitoneal and Laparoscopic versus Robotic Adrenalectomy. Chai, YJ., Kwon, H., Yu, HW., et al.[2022]

A systematic review of nine trials found that robotic adrenalectomy has similar conversion rates and operative times compared to laparoscopic adrenalectomy, indicating comparable efficacy in these aspects.

Robotic adrenalectomy resulted in shorter hospital stays and less estimated blood loss compared to laparoscopic procedures, suggesting potential safety benefits, although cost and technical challenges remain barriers to its widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot assisted adrenalectomy: a handy tool or glorified obsession? Pahwa, M.[2020]

In a study of 1,005 patients undergoing adrenalectomy, robotic adrenalectomy showed a significantly lower complication rate (1.6%) compared to conventional laparoscopic surgery (16.5%), indicating a safer option for patients.

Patients who underwent robotic adrenalectomy also experienced a shorter hospital stay (82.1% vs 28.8%), suggesting that this technique may lead to quicker recovery times compared to traditional laparoscopic methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted versus conventional laparoscopic adrenalectomy: Results from the EUROCRINE Surgical Registry. Vatansever, S., Nordenström, E., Raffaelli, M., et al.[2022]

In a study of 37 patients undergoing transperitoneal robotic adrenalectomy over 10 years, the procedure demonstrated high effectiveness with an average operating time of 213 minutes and minimal estimated blood loss of 74 mL.

Despite some postoperative complications leading to unplanned readmissions, the overall safety profile was acceptable, indicating that robotic adrenalectomy can be a valuable alternative to traditional laparoscopic methods for adrenal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Adrenalectomy: A 10-Year Clinical Experience at a Tertiary Medical Center. Francis, A., Mellert, L., Parekh, N., et al.[2022]

In a study of 190 laparoscopic and 281 robotic adrenalectomies, robotic surgery resulted in shorter operative times and hospital stays, as well as less blood loss and fewer conversions to open surgery, particularly for pheochromocytoma and malignant tumors.

Both surgical methods had similar morbidity rates, suggesting that robotic adrenalectomy offers significant perioperative advantages without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic versus robotic lateral transabdominal adrenalectomy. Isiktas, G., Akgun, E., Berber, E.[2023]

Robotic adrenalectomy (RA) is emerging as a viable option for adrenalectomy, alongside the standard laparoscopic approach (LA), as robotic technology becomes more widely adopted in medical centers.

This review highlights the need to evaluate the potential advantages of robotic adrenalectomy against its higher costs compared to laparoscopic adrenalectomy, although specific data on efficacy and safety were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic lateral transabdominal adrenalectomy. Nomine-Criqui, C., Brunaud, L., Germain, A., et al.[2015]

Robotic adrenalectomy showed similar intraoperative times compared to conventional laparoscopic techniques for both lateral transabdominal and posterior retroperitoneal approaches, despite larger tumor sizes in the robotic group.

Patients undergoing robotic adrenalectomy experienced lower morbidity rates (2% vs 10%) and shorter hospital stays (1.1 days vs 1.5 days), indicating a potential safety and recovery advantage of the robotic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intraoperative time use and perioperative outcomes for robotic versus laparoscopic adrenalectomy. Karabulut, K., Agcaoglu, O., Aliyev, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7803606/

Minimally Invasive Adrenal Surgery - PMC As minimally invasive surgery, laparoscopic or retroperitoneoscopic adrenalectomy is expected to yield excellent surgical outcomes and minor complications ...

2. jurolsurgery.org jurolsurgery.org/articles/can-laparoscopic-adrenalectomy-be-a-reliable-method-for-adrenal-masses-larger-than-4-cm-our-clinical-outcomes/jus.galenos.2024.2024-9-9

Can Laparoscopic Adrenalectomy Be A Reliable Method ... However, many publications have shown that laparoscopic adrenalectomy is a safe and effective method for large adrenal masses (>4-5 cm) (14-18). Novitsky et al.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9193177/

Laparoscopic adrenalectomy. A new standard of care Conclusions: Laparoscopic adrenalectomy can be performed safety and with the benefits associated with minimally invasive surgery. In addition, the procedure is ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1743919122005568

Safety and effectiveness of minimally invasive ... This systematic review and meta-analysis compared the safety and effectiveness of minimally invasive adrenalectomy (MIA) with open adrenalectomy (OA) in ...

5. emedicine.medscape.com emedicine.medscape.com/article/1894961-overview

Laparoscopic Right Adrenalectomy It is now the technique of choice for most benign adrenal lesions because of the decreased blood loss, lower morbidity, shorter hospitalization, faster ...

6. umms.org umms.org/ummc/health-services/surgery/endocrine-surgery/conditions/adrenal-gland/risks

Risks of Adrenal Surgery In open adrenalectomies, the common complications are lung related. Pneumonia and atelectasis occurs in approximately 6% of open adrenalectomies.

7. mayoclinic.org mayoclinic.org/tests-procedures/adrenalectomy/about/pac-20385243

Adrenalectomy Adrenalectomy has the same risks as other major surgeries — bleeding, infection and a bad reaction to the anesthesia. Other possible risks ...

8. mis.wustl.edu mis.wustl.edu/patient-care/laparoscopic-adrenalectomy/

Laparoscopic Adrenalectomy As with any operation, there is a risk of complications. Complications during the operation may include: ... Wound problems, blood clots, heart attacks and other ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25502499/

[Complications of minimally invasive adrenalectomy] Die incidence of intraoperative and postoperative complications ranges from 0 % to 15 % for unilateral adrenalectomy and rises up to 23 % for bilateral surgery.