Clinical trial · Observational
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia
NCT06316401CI-TRIAL-00075150completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal (Colon or Rectal) Cancer | Childhood Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD of large LSTs under SA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients underwent endoscopic submucosal dissection under spinal anesthesia
- description
- 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.
- interventionNames
- Procedure: ESD of large LSTs under SA
Primary outcomes (2)
- measure
- Technical success of ESD under SA
- timeFrame
- Immediately after the procedure
- description
- Technical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.