Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia

Azienda USL Modena20 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal (Colon or Rectal) Cancer

Interventions

ESD of large LSTs under SAPROCEDURE

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥18 years * American Society of Anaesthesiologists (ASA) score I-IV * ability to give informed consent Exclusion Criteria: * age \<18 years * ASA score V * allergy to medications used for spinal anesthesia * pregnancy * breastfeeding

Locations (1)

Mauro Manno

Carpi, MO, Italy

Outcomes

Primary Outcomes

Technical success of ESD under SA

Technical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.

Time frame: Immediately after the procedure

Safety of ESD under SA

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.

Time frame: periprocedurally

Secondary Outcomes

Intra- and post-procedural need for additional opioid or other analgesic drug administration

Time frame: periprocedurally

ESD- and colonoscopy-related AEs

Perforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation

Time frame: periprocedurally

Length of hospital stay

length of hospital stay

Time frame: At delivery

Median ESD duration

Time frame: Immediately after the procedure

Data from ClinicalTrials.gov

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