Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

Clostridium difficile (C. difficile) affects more than 3 million patients per year in the
United States, and is increasing in frequency [2-15]. Approximately 8 % of hospitalized
patients are infected with C. difficile [12]. Of these patients 3% - 8% will develop the
fulminant disease, defined as C. difficile colitis with significant systemic toxic effects
and shock, resulting in need for colectomy or death [2].

Fulminant C. difficile colitis (FCDC) is a highly lethal disease with mortality rates
ranging between 12% - 80% [2-6,8-15]. A retrospective study in our own institution
identified a 35% mortality rate for FCDC [2].

The indications for surgical management of patients with FCDC are not clearly defined,
however most advocate surgical intervention in patients with worsening clinical exams,
peritonitis, or patients in shock. Total abdominal colectomy (also called subtotal
colectomy) with end ileostomy has been advocated as the operation of choice and has been
demonstrated to marginally improve survival compared to non-operative management in these
critically ill patients. A total abdominal colectomy has many disadvantages. Most important,
mortality rates continue to range from 35-80%. Additionally, total abdominal colectomy
(subtotal colectomy) can result in significant morbidity, and many survivors will have a
permanent ileostomy.

The new treatment option that will be tested in this randomized controlled trial (RCT) may
change the standard of care. Based on a small prospective series from Neal and colleagues
[1] the investigators propose an alternative surgical approach for the management of FCDC,
which may prove a safer and simpler option. Based on the nature of the disease as a
bacterial toxin-mediated mucosal inflammatory process with delayed and indirect systemic
threats to life, the investigators think that minimally invasive ileal diversion with
intraoperative colonic lavage using a high volume polyethylene glycol/electrolyte solution
will clear Clostridium difficile infection resulting in eradication of FCDC while preserving
the colon.

Inclusion Criteria:

1. Adult patients >18 years of age

2. Able to provide informed consent, or presence of a legally authorized representative
able and willing to provide informed consent

3. Candidates for total abdominal colectomy due to severe, complicated FCDC per
consulting surgeon and team providing care

4. Subjects must meet criteria for operative management of FCDC (find in detailed
protocol)

Exclusion Criteria:

1. Children (<18 years of age)

2. Allergy or hypersensitivity reaction to study medications: Vancomycin, Metronidazole,
GoLytely

3. Intra-operative evidence of colonic perforation

4. Intra-operative evidence of colonic necrosis

5. Pregnancy (this will be ruled out by a urine test at the time of indication for
surgery)

6. Prisoners