Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

Stopped early · Not applicable

Conditions studied: Clostridium Difficile Colitis

In brief

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.

Key facts

Study ID

NCT01441271

Run by

Massachusetts General Hospital

People needed

1

Starts

2012-09-01

Expected to finish

2013-09-01

Last updated by the study team

2015-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients >18 years of age
• Able to provide informed consent, or presence of a legally authorized representative able and willing to provide informed consent
• Candidates for total abdominal colectomy due to severe, complicated FCDC per consulting surgeon and team providing care
• Subjects must meet criteria for operative management of FCDC (find in detailed protocol)

You may not qualify if…

• Children (<18 years of age)
• Allergy or hypersensitivity reaction to study medications: Vancomycin, Metronidazole, GoLytely
• Intra-operative evidence of colonic perforation
• Intra-operative evidence of colonic necrosis
• Pregnancy (this will be ruled out by a urine test at the time of indication for surgery)
• Prisoners

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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