Comparing laparoscopic and robotic adrenal surgery
Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy: a Single-center Randomized Prospective Trial
NA · The Cleveland Clinic · NCT06407024
This study is testing whether laparoscopic or robotic surgery works better for removing adrenal tumors to help improve patient care and surgical practices.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06407024 on ClinicalTrials.gov |
What this trial studies
This study compares laparoscopic and robotic lateral transabdominal adrenalectomy to evaluate patient outcomes and surgeon efficiency. Both procedures are standard care for adrenal tumors, but there is limited comparative data available. The research aims to provide insights that could enhance patient care and optimize resource utilization in adrenal surgery. By analyzing the effectiveness and safety of each approach, the study seeks to inform best practices in surgical techniques.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 75 with a diagnosis of an adrenal tumor planned for minimally invasive adrenalectomy.
Not a fit: Patients requiring open adrenalectomy due to aggressive cancer or those with extensive surgical history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing adrenal surgery.
How similar studies have performed: Previous studies have shown mixed results, with some favoring laparoscopic approaches and others robotic, indicating that this comparative analysis is necessary and timely.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Eren Berber, MD — The Cleveland Clinic
- Study coordinator: Kimberly Jenkins
- Email: jenkink@ccf.org
- Phone: 216 445-4791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adrenalectomy