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

Colorectal (Colon or Rectal) Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316401
• Other study ID #: 03-2024
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 3, 2024

Study information

• Verified date: March 2024
• Source: Azienda USL Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 3, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal (Colon or Rectal) Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• ESD of large LSTs under SA
endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Locations

Country	Name	City	State
Italy	Mauro Manno	Carpi	MO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after the procedure
Primary	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.	periprocedurally
Secondary	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	periprocedurally
Secondary	ESD- and colonoscopy-related AEs	Perforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation	periprocedurally
Secondary	Length of hospital stay	length of hospital stay	At delivery
Secondary	Median ESD duration	Median ESD duration	Immediately after the procedure