Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis

NCT01441271 | Terminated DMC

• 1 other identifier: 2012-P-000138/1; MGH
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Colitis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Both groups will be compared using mortality as the primary outcome.

  28 day

Secondary Outcomes (4)

• ICU Length of Stay (LOS

  during hospitalization

• Hospital LOS

  hospitalization

• ventilation days

  while in ICU

• morbidity

  during hospitalization

Study Arms (2)

total abdominal colectomy

ACTIVE COMPARATOR

the standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy

Procedure: total abdominal colectomy

Ileal diversion and lavage

EXPERIMENTAL

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.

Procedure: Ileal diversion and lavage

Interventions

Ileal diversion and lavage PROCEDURE

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.

Ileal diversion and lavage

total abdominal colectomy PROCEDURE

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.

Also known as: subtotal colectomy

total abdominal colectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Marc de Moya, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 17, 2011
• First Posted: September 27, 2011
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2013
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (1)