Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of ESD under SA
研究概览
简要总结
The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) >35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS).
详细描述
Background and study aim: Endoscopic submucosal dissection (ESD) of large colorectal lesions requires the patient to be in a still position for a long time. Both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (ARAEs), especially in frail patients. Conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. Spinal anesthesia (SA) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. As the use of SA in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of SA in large (>35 mm) recto-sigmoid lesion ESD.
Patients and methods: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) >35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). The secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, ESD-related adverse eventss, length of hospital stay, and median ESD duration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years
- •American Society of Anaesthesiologists (ASA) score I-IV
- •ability to give informed consent
排除标准
- •age <18 years
- •ASA score V
- •allergy to medications used for spinal anesthesia
- •pregnancy
- •breastfeeding
结局指标
主要结局
Safety of ESD under SA
时间窗: periprocedurally
Safety was evaluated intra- and post-procedurally by recording anesthesia-related adverse events (ARAEs). Major ARAEs included death, anaphylaxis and severe cardiorespiratory or neurologic AEs. Minor ARAEs included any other cardiorespiratory or neurologic AEs, headache, acute urinary retention and itching.
Technical success of ESD under SA
时间窗: Immediately after the procedure
Technical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.
次要结局
- Median ESD duration(Immediately after the procedure)
- Length of hospital stay(At delivery)
- Intra- and post-procedural need for additional opioid or other analgesic drug administration(periprocedurally)
- ESD- and colonoscopy-related AEs(periprocedurally)
研究者
Dr. Mauro Manno
Directore Gastroenterology and Endoscopy Unit
Azienda USL Modena