Health TrialsbyHealthPanel

Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy

ConditionAdrenalectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Cleveland Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • laparoscopic transabdominal adrenalectomy

    Procedure/Surgery

    Adrenalectomy performed by laparoscopic approach

  • robotic transabdominal adrenalectomy

    Procedure/Surgery

    Adrenalectomy performed by robotic approach

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: 27 patients assigned to laparoscopic transabdominal adrenalectomyActive comparator 1 intervention
Group B: 27 patients assigned to robotic transabdominal adrenalectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skin-to-skin operative time

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

Time frame
1 day

Secondary outcomes

1

Conversion to robotic or laparoscopic approach

The number of patients who are required to convert to either a robotic or laparoscopic approach - a departure from what they were randomized to.

Time frame
1 day
2

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

Post operative patient pain ratings on a scale of 0 - 10

Time frame
1 day
3

Hospital stay

Length of hospital stay as measured in days

Time frame
3 days
4

Cost

Reported as disposable/reusable median cost ratio and operating room time-cost ratio.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
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