Clinical trial NCT06316401: Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia
Official title: Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal (Colon or Rectal) Cancer
Keywords: ESD
Spinal Anesthesia
colorectal lesions
LST
Laterally Spreading Tumor
endoscopic submucosal dissection
deep sedation
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients eligibility underwent ESD for large LSTs under SA

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success of ESD under SA
timeFrame: Immediately after the procedure
measure: Safety of ESD under SA
timeFrame: periprocedurally
Secondary outcomes:
measure: Intra- and post-procedural need for additional opioid or other analgesic drug administration
timeFrame: periprocedurally
measure: ESD- and colonoscopy-related AEs
timeFrame: periprocedurally
measure: Length of hospital stay
timeFrame: At delivery
measure: Median ESD duration
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Mauro Manno
state: MO
Study officials:
affiliation: AUSL Modena
name: Mauro Manno, MD
role: PRINCIPAL_INVESTIGATOR
References: