Recruiting

Laparoscopic vs. Robotic

Sponsor:

The Cleveland Clinic

Code:

NCT06407024

Conditions

Adrenalectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

laparoscopic transabdominal adrenalectomy

robotic transabdominal adrenalectomy

Study Details

Brief 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.

The information from this study will help improve patient care, patient outcomes and maximize the appropriate utilization of resources in adrenal surgery.

Conditions

Adrenalectomy

Study ID

NCT06407024

Start date

May 22, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 27 patients assigned to laparoscopic transabdominal adrenalectomy

active comparator: 27 patients assigned to robotic transabdominal adrenalectomy

Interventions

laparoscopic transabdominal adrenalectomy

Adrenalectomy performed by laparoscopic approach

robotic transabdominal adrenalectomy

Adrenalectomy performed by robotic approach

Primary outcome measure

  • Skin-to-skin operative time [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Kimberly Jenkins

216 445-4791jenkink@ccf.org

Andrea Parianos

216 210-7832debsa@ccf.org

Locations

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kimberly Jenkins

216-445-4791jenkink@ccf.org

Andrea Parianos

216 210-7832debsa@ccf.org

Principal Investigator:

Eren Berber, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-02-02.