Loop Ileostomy With Colonic Lavage for Fulminant Clostridium Difficile Colitis
Fulminant Clostridium Difficile Colitis
About this trial
This is an interventional treatment trial for Fulminant Clostridium Difficile Colitis focused on measuring clostridium difficile, colitis, colon
Eligibility Criteria
Inclusion Criteria:
- Adult patients >18 years old
- Able to provide informed consent, or presence of a legally authorized representative
- Meets criteria for operative management as below (Table 1).
Table 1. Criteria for FCDC (criteria A, B and C all need to be met)
A. A diagnosis of FCDC as determined by a history consistent with C.Difficile infection and one of the following:
- A positive toxin assay
- Endoscopic finding of pseudomembranes
- CT scan findings of pancolitis
B. At least 2 of the following:
- Worsening abdominal distention or abdominal pain
- Sepsis: 2 of the following (HR>100bpm, MAP<60mmHg, temperature>38.5C or<36.5C, and fluid requirement >2L)
- New onset ventilatory requirement
- Vasopressor requirement
- Mental status changes
- Unexplained clinical deterioration
- Stable elevated leukocytosis or leukopenia, or worsening leukocytosis, defined as >20,000 or <3,000x109/L
C. Attending physician of record (ICU or medicine/surgery) is in agreement with an operative approach
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Exclusion Criteria:
- Children (<18 years old)
- Allergy to vancomycin or polyethyleneglycol
- Colonic perforation or necrosis
- Pregnancy
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Loop ileostomy with colonic lavage
Total abdominal colectomy with end ileostomy
creation of a loop ileostomy, intraoperative colonic lavage with warmed polyethylene glycol via the ileostomy and postoperative antegrade instillation of vancomycin flushes into the diseased colon via the ileostomy
Removal of entire colon with preservation of rectal stump and construction of end ileostomy