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

NCT06316401 | Completed

• 1 other identifier: 03-2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal (Colon or Rectal) Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

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

  periprocedurally

• ESD- and colonoscopy-related AEs

  periprocedurally

• Length of hospital stay

  At delivery

• Median ESD duration

  Immediately after the procedure

Study Arms (1)

Patients underwent endoscopic submucosal dissection under spinal anesthesia

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

Interventions

ESD of large LSTs under SA PROCEDURE

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Patients underwent endoscopic submucosal dissection under spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligibility underwent ESD for large LSTs under SA

You may qualify if:

• age ≥18 years
• American Society of Anaesthesiologists (ASA) score I-IV
• ability to give informed consent

You may not qualify if:

• age \<18 years
• ASA score V
• allergy to medications used for spinal anesthesia
• pregnancy
• breastfeeding

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

Mauro Manno

Carpi, MO, 41012, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mauro Manno, MD

  AUSL Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directore Gastroenterology and Endoscopy Unit

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: March 3, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

IT (1)