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

NCT ID: NCT06316401

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-03-03

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.

Conditions

Colorectal (Colon or Rectal) Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

ESD of large LSTs under SA

Intervention Type: PROCEDURE

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Interventions

ESD of large LSTs under SA

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda USL Modena

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mauro Manno

Directore Gastroenterology and Endoscopy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro Manno, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL Modena

Locations

Mauro Manno

Carpi, MO, Italy

Countries

Italy

Other Identifiers

03-2024

Identifier Type: -

Identifier Source: org_study_id