跳至主要内容
临床试验/NCT06407024
NCT06407024招募中不适用

Laparoscopic Versus Robotic Lateral Transabdominal Adrenalectomy: a Single-center Randomized Prospective Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
2
主要终点
Skin-to-skin operative time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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

研究组 & 干预措施

27 patients assigned to laparoscopic transabdominal adrenalectomy

Active Comparator

干预措施: laparoscopic transabdominal adrenalectomy (Procedure)

27 patients assigned to robotic transabdominal adrenalectomy

Active Comparator

干预措施: robotic transabdominal adrenalectomy (Procedure)

结局指标

主要结局

Skin-to-skin operative time

时间窗: 1 day

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

次要结局

  • Postoperative pain scores (according to visual assessment score 0-10, with 0 being non pain and 10 being worst pain)(1 day)
  • Conversion to robotic or laparoscopic approach(1 day)
  • Cost(1 day)
  • Hospital stay(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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