An observational study in Colorectal (Colon or Rectal) Cancer, sponsored by Azienda USL Modena. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Azienda USL Modena · Observational
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 20 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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All patients eligibility underwent ESD for large LSTs under SA
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: ESD of large LSTs under SA
endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia
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
Intra- and post-procedural need for additional opioid or other analgesic drug administration
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
Median ESD duration
Time frame: Immediately after the procedure
Plan to share: Undecided
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Azienda USL Modena