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Completed

NCT Number: NCT06316401

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESD of large LSTs under SA

Procedure

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Primary outcomes

  1. Technical success of ESD under SA

    Time frame: 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.

  2. Safety of ESD under SA

    Time frame: 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.

Secondary outcomes

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

    Time frame: periprocedurally

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

  2. ESD- and colonoscopy-related AEs

    Time frame: periprocedurally

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

  3. Length of hospital stay

    Time frame: At delivery

    length of hospital stay

  4. Median ESD duration

    Time frame: Immediately after the procedure

    Median ESD duration

Sponsors and collaborators

Lead sponsor

Azienda USL Modena

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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