Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Interventions
- Procedure: ESD of large LSTs under SA
- Registration Number
- NCT06316401
- Lead Sponsor
- Azienda USL Modena
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- age ≥18 years
- American Society of Anaesthesiologists (ASA) score I-IV
- ability to give informed consent
- age <18 years
- ASA score V
- allergy to medications used for spinal anesthesia
- pregnancy
- breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients underwent endoscopic submucosal dissection under spinal anesthesia ESD of large LSTs under SA We collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA. SA was carried out in a sitting position, following a strictly aseptic technique. After recognition of L2-L3 intervertebral space through landmark technique, a 25 Gauge needle was inserted and the correct positioning was confirmed by detecting free flow of cerebrospinal fluid. Subsequently, 10-12 mg of hyperbaric bupivacaine + sufentanil 2 mcg according to the decision of the anesthetist was administered intrathecally without barbotage. Subsequently, the patient underwent ESD of the colorectal lesion.
- Primary Outcome Measures
Name Time Method Safety of ESD under SA 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 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.
- Secondary Outcome Measures
Name Time Method Median ESD duration Immediately after the procedure Median ESD duration
Length of hospital stay At delivery length of hospital stay
Intra- and post-procedural need for additional opioid or other analgesic drug administration periprocedurally Intra- and post-procedural need for additional opioid or other analgesic drug administration
ESD- and colonoscopy-related AEs periprocedurally Perforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation
Trial Locations
- Locations (1)
Mauro Manno
🇮🇹Carpi, MO, Italy