Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy

NCT06407024 | Recruiting

• 1 other identifier: 23-422
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skin-to-skin operative time

  The duration of the procedure measured in hours and/or minutes

  1 day

Secondary Outcomes (4)

• Conversion to robotic or laparoscopic approach

  1 day

• Postoperative pain scores (according to visual assessment score 0-10, with 0 being non pain and 10 being worst pain)

  1 day

• Hospital stay

  3 days

• Cost

  1 day

Study Arms (2)

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

Interventions

laparoscopic transabdominal adrenalectomy PROCEDURE

Adrenalectomy performed by laparoscopic approach

27 patients assigned to laparoscopic transabdominal adrenalectomy

robotic transabdominal adrenalectomy PROCEDURE

Adrenalectomy performed by robotic approach

27 patients assigned to robotic transabdominal adrenalectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Eren Berber, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Jenkins

CONTACT

216 445-4791; jenkink@ccf.org

Andrea Parianos

CONTACT

216 210-7832; debsa@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)