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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06316401
Enrollment
20
Registered
2024-03-18
Start date
2021-01-01
Completion date
2024-03-03
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal (Colon or Rectal) Cancer

Keywords

ESD, Spinal Anesthesia, colorectal lesions, LST, Laterally Spreading Tumor, endoscopic submucosal dissection, deep sedation

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.

Interventions

PROCEDUREESD of large LSTs under SA

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Sponsors

Azienda USL Modena
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Technical success of ESD under SAImmediately after the procedureTechnical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.
Safety of ESD under SAperiprocedurallySafety 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

MeasureTime frameDescription
Median ESD durationImmediately after the procedureMedian ESD duration
Length of hospital stayAt deliverylength of hospital stay
Intra- and post-procedural need for additional opioid or other analgesic drug administrationperiprocedurallyIntra- and post-procedural need for additional opioid or other analgesic drug administration
ESD- and colonoscopy-related AEsperiprocedurallyPerforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026