Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

This study has been terminated.
(Numer of eligible patients markedly decreased since the initiation of the study.)
Sponsor:
Information provided by (Responsible Party):
Marc A. de Moya, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01441271
First received: September 17, 2011
Last updated: May 19, 2014
Last verified: May 2014

September 17, 2011
May 19, 2014
September 2012
October 2012   (final data collection date for primary outcome measure)
Mortality [ Designated as safety issue: No ]
Both groups will be compared using mortality as the primary outcome.
Same as current
Complete list of historical versions of study NCT01441271 on ClinicalTrials.gov Archive Site
  • ICU Length of Stay (LOS [ Designated as safety issue: No ]
    Length of stay in ICU (days)
  • Hospital LOS [ Designated as safety issue: No ]
    Length of stay in hospital (days)
  • ventilation days [ Designated as safety issue: No ]
    Days that patient is being mechanically ventilated.
  • morbidity [ Designated as safety issue: No ]
    Morbidity measured as: DVT/PE rate, surgical site infection, urinary tract infection, pneumonia, inadvertent enterotomy, re-operation related to ileostomy, and 'ileostomy tube' migration.
Same as current
Not Provided
Not Provided
 
Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis
Diverting Loop Ileostomy and Colonic Lavage: An Alternative To Total Abdominal Colectomy For The Treatment Of Fulminant Clostridium Difficile Colitis. A Randomized Controlled Trial.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Clostridium Difficile Colitis
  • Procedure: Ileal diversion and lavage
    The surgical approach involves an attempted laparoscopic creation of a loop ileostomy after visually assessing the colon to assure viability. If the loop is unable to be safely performed laparoscopically an open loop ileostomy will be performed. Intraoperatively, 8 liters of warmed polyethylene glycol 3350/electrolyte solution [GoLytely®; Braintree Laboratories] will be infused into the colon via the ileostomy and collected via a rectal drainage tube. Post-operatively, the patients will receive antegrade vancomycin flushes [500 mg in 500 ml of Lactated Ringers; q8 hours for duration of 10 days] via a Malecot catheter [24 French] left in the efferent limb of the ileostomy (Figure 1). Additionally patients will be continued on intravenous metronidazole [500mg q8 hours] for 10 days.
  • Procedure: total abdominal colectomy
    The surgical approach of the colon in a total abdominal colectomy involves a midline incision. The complete colon in the abdomen (from ileum to rectum) will be removed and an end ileostomy is performed.
    Other Name: subtotal colectomy
  • Active Comparator: total abdominal colectomy
    the standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy
    Intervention: Procedure: total abdominal colectomy
  • Experimental: 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.
    Intervention: Procedure: Ileal diversion and lavage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01441271
2012-P-000138/1; MGH
Yes
Marc A. de Moya, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Marc de Moya, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP