WithdrawnNot Applicable

Epidural for Ogilvie's Syndrome

Stopped: This was a pilot study aimed at assessing feasibility of further assessing epidural as a treatment for Ogilvie's. There were no eligible patients that were enrolled throughout the two years of accrual. Thus we deemed the study not feasible.

Canada0Started 2021-09-01

Plain-language summary

Epidural anesthesia may represent a safe and effective pharmacological tool in the management of Ogilvie's Syndrome. This pilot study aims to demonstrate feasibility, safety, and efficacy of epidural anesthesia to set the stage for adequately powered future randomized controlled trials (RCTs) in order to assess the efficacy of epidural anesthetic as a pharmacological treatment strategy for Ogilvie's Syndrome. Ultimately, this research may prompt further investigation and establish standardized criteria for managing Ogilvie's Syndrome patients with epidural anesthesia.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years old * Admitted to an inpatient ward at SJHH with a documented diagnosis of Ogilvie's Syndrome/Acute Colonic Pseudo-Obstruction * Failed conservative management for at least 24-48 hours Exclusion Criteria: * Hemodynamic instability * Peritonitis on abdominal examination * Cecal diameter greater than 12cm or evidence of hollow viscus perforation on abdominal imaging (e.g. bowel wall thickening, mesenteric stranding, hypoenhancement of bowel wall) * Documented allergic reaction to anesthetic agent * Bacteremia * Local soft tissue infection at the puncture site * Coagulopathy or therapeutic anticoagulation * Intracranial pathology leading to increased intracranial pressure * Prior spinal surgery * Unstable severe respiratory or cardiovascular disease * Previously managed with epidural anesthesia for Ogilvie's Syndrome * Inability/unwilling to consent to trial treatment

What they're measuring

Recruitment rate

Timeframe: 2 years

Successful epidural insertion

Timeframe: 2 years

Follow-up rate

Timeframe: 2 years

Epidural-related morbidity

Timeframe: 30 days

Rate of clinical resolution

Timeframe: 2 years

Rate of radiological resolution

Timeframe: 2 years

Trial details

NCT IDNCT04600427

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Ogilvie Syndrome trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.