Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

Mass General Brigham

Status: Terminated

Conditions: Clostridium Difficile Colitis

Treatments: Procedure: total abdominal colectomy; Procedure: Ileal diversion and lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01441271

2012-P-000138/1 MGH;

Details and patient eligibility

About

The investigators hypothesize 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 Fulminant C. difficile colitis (FCDC) while preserving the colon. Furthermore, the investigators hypothesize this will reduce morbidity and mortality compared to total abdominal colectomy.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

total abdominal colectomy

Active Comparator group

Description:

the standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy

Treatment:

Procedure: total abdominal colectomy

Ileal diversion and lavage

Experimental group

Description:

The tested intervention in this trial will be: intraoperative colonic lavage using a high volume polyethylene glycol/electrolyte solution, that will clear Clostridium difficile infection resulting in eradication of FCDC while preserving the colon.

Treatment:

Procedure: Ileal diversion and lavage