Clinical trial NCT01441271: Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis
Official title: Diverting Loop Ileostomy and Colonic Lavage: An Alternative To Total Abdominal Colectomy For The Treatment Of Fulminant Clostridium Difficile Colitis. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clostridium Difficile Colitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 28 day
Secondary outcomes:
measure: ICU Length of Stay (LOS
timeFrame: during hospitalization
measure: Hospital LOS
timeFrame: hospitalization
measure: ventilation days
timeFrame: while in ICU
measure: morbidity
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marc de Moya, MD
role: PRINCIPAL_INVESTIGATOR
References: