Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

Not Applicable

Terminated

• Conditions: Clostridium Difficile Colitis
• Interventions: Procedure: total abdominal colectomy; Procedure: Ileal diversion and lavage

• Registration Number: NCT01441271
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2011-09-17
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-27
• Study Start: 2012-09
• Primary Completion: 2012-10
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total abdominal colectomy	total abdominal colectomy	the standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy
Ileal diversion and lavage	Ileal diversion and lavage	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.

Primary Outcome Measures

Name	Time	Method
Mortality	28 day	Both groups will be compared using mortality as the primary outcome.

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay (LOS	during hospitalization	14 days
Hospital LOS	hospitalization	1 year
morbidity	during hospitalization	1 year
ventilation days	while in ICU	1 year

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States