TerminatedNot Applicable

Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

Stopped: Numer of eligible patients markedly decreased since the initiation of the study.

United States1 participantsStarted 2012-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Mortality

Timeframe: 28 day

Trial details

NCT IDNCT01441271

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Clostridium Difficile Colitis trials