Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06407024 |
| Other study ID # |
23-422 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
The Cleveland Clinic |
| Contact |
Kimberly Jenkins |
| Phone |
216 445-4791 |
| Email |
jenkink[@]ccf.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Adrenalectomy used to be done through big open chevron, subcostal or thoraco-abdominal
incisions that led to significant recovery and morbidity. In 1990s, the description of
laparoscopic adrenalectomy revolutionized the care of these patients by converting the
procedure into a minimally invasive operation with a short hospital stay and recovery. Since
then, many centers have reported the safety and efficacy of laparoscopic adrenalectomy.
Laparoscopic surgery uses rigid, straight instruments operated by the surgeons under the
visual guidance of a two-dimensional video platform.
In the late 2000s, robotic systems have been developed that incorporated articulating wristed
instruments used with a three-dimensional computerized video platform. Over the past two
decades, robotic systems have penetrated many thoracic, cardiac and abdominal procedures.
A review of the National inpatient database in 2016 showed that 32.7% of the adrenalectomies
in the US are being done robotically and 48.5% laparoscopically. Nevertheless, there are
scant comparative data and only two randomized studies comparing laparoscopic with robotic
adrenalectomy, one of which suffers from a small sample size (10 patients in each group
Morino et al Surg Endosci) and the other from exclusion of tumor types (pheochromocytoma only
Ma W et al Eur J Surg Oncol). The first study found laparoscopic approach to be superior and
the latter study robotic approach to be more advantageous. Both studies highlighted the cost
of robotic surgery to be a disadvantage versus laparoscopic approach. Underscoring the lack
of data to recommend one technique versus the other, a meta-analysis concluded that robotic
adrenalectomy is a safe and feasible procedure with similar clinical outcomes as the
laparoscopic approach and recommended high quality randomized clinical trials to determine
whether laparoscopic vs robotic approach was superior to perform adrenalectomy.
The study team's clinic has a high-volume minimally invasive adrenalectomy program with a
good mixture of laparoscopic and robotic surgical expertise, performing close to 100 surgical
cases a year. There are a number of barriers to performing the randomized studies required
for adrenalectomy. The first one is the adrenal surgery volume. An average general surgeon
does one adrenal surgery a year. A high-volume adrenal surgeon is considered to do > 4-6
adrenalectomies a year. Furthermore, there are only a few centers in the world that possesses
a large both laparoscopic and robotic adrenalectomy experience. Being a unique adrenal
surgery center, the study team believes that their center is one of the few centers in the
world qualified to perform a randomized clinical trial comparing laparoscopic with robotic
adrenalectomy. The study team believes that such a study will help understand whether one
approach is more advantageous over the other regarding surgical outcomes, especially with the
increasing use of robotics in surgical procedures.
