Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407024
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-06
Brief Title:
Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy a Single-center Randomized Prospective Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 327 of the adrenalectomies in the US are being done robotically and 485 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 teams 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
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 327 of the adrenalectomies in the US are being done robotically and 485 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 teams 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None