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

Trial Summary

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 data supports the effectiveness of the treatment Laparoscopic vs Robotic Lateral Transabdominal Adrenalectomy?

Studies show that both robotic and laparoscopic adrenalectomy have similar outcomes and complications, but robotic surgery may not offer significant advantages over the traditional laparoscopic approach. Laparoscopic posterior retroperitoneal adrenalectomy is noted to be more effective than the lateral transabdominal approach in terms of operation time and hospital stay. ^{1 2 3 4 5}

Is robotic or laparoscopic adrenalectomy safe for humans?

Both robotic and laparoscopic adrenalectomy are considered safe for humans, with studies showing that the safety of robotic adrenalectomy has been widely demonstrated and is comparable to the conventional laparoscopic approach. ^{1 3 5 6 7}

How does the treatment of laparoscopic vs robotic adrenalectomy differ from other treatments for adrenal gland conditions?

Laparoscopic adrenalectomy is the standard method for removing adrenal gland tumors, while robotic adrenalectomy is a newer option that offers similar outcomes but with potentially higher costs. The robotic approach may offer advantages in certain cases, but more cost reductions and technical advances are needed for it to become more widely used. ^{1 2 3 4 8}

What is the purpose of this 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.

Research Team

Eren Berber, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic versus robotic lateral transabdominal adrenalectomy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of intraoperative time use and perioperative outcomes for robotic versus laparoscopic adrenalectomy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Robotic lateral transabdominal adrenalectomy. [2015]

4. Egypt pubmed.ncbi.nlm.nih.gov

Systematic Review of Surgical Approaches for Adrenal Tumors: Lateral Transperitoneal versus Posterior Retroperitoneal and Laparoscopic versus Robotic Adrenalectomy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted versus conventional laparoscopic adrenalectomy: Results from the EUROCRINE Surgical Registry. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Robotic Adrenalectomy: A 10-Year Clinical Experience at a Tertiary Medical Center. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Robotic versus laparoscopic resection of large adrenal tumors. [2012]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Robot assisted adrenalectomy: a handy tool or glorified obsession? [2020]