Status:
TERMINATED
Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Clostridium Difficile Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 i...
Detailed 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 infecte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01441271
Start Date
September 1 2012
End Date
September 1 2013
Last Update
May 1 2015
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114