Loop Ileostomy With Colonic Lavage for Fulminant Clostridium Difficile Colitis

Summary

LAY SUMMARY

Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe illness. The present treatment for fulminant colitis is a total abdominal colectomy with end ileostomy. This means, a surgery is performed which removes the entire diseased colon. The end of the small intestine is then brought out to the front of the abdomen as a stoma, and the patient wears a bag. Despite this invasive treatment, there remains a significant rate of death (38-50%). In addition, patients have a long recovery after this long operation and many (67%) will not be fit for a second big operation to remove the stoma (that is to reconnect the intestine).

The purpose of our study is to determine if a loop ileostomy with colonic lavage will result in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is washed with a warm solution (like the solution used in a colonoscopy preparation) and then treated with an antibiotic via this ileostomy. So far, one study has been done using a loop ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42 patients that underwent the standard of care (complete removal of the colon with end ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in rate of death compared to the standard of care. Also, in the study, patients who underwent a loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma). The purpose of this study is to see if a loop ileostomy with colonic lavage can treat patients with fulminant colitis with less risk of death than the standard of care.

Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria, he/she will be asked by the surgeon on-call if they would like to participate in this research study. If they agree to be in this study, they must first sign a consent form. They may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or the standard of care arm. After surgery, all patients will receive the same standard routine care. During the hospital stay, information will be taken from their chart for purposes of the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months after surgery. If the patient decides to be in the study, the patient will be expected to complete all the follow up study visits. The patient will not be required to do anything extra or have any extra tests if they decide to be in the study at any of these visits.

Conditions

• Fulminant Clostridium Difficile Colitis

Interventions

PROCEDURE

Loop Ileostomy with colonic lavage

creation of a loop ileostomy, intraoperative colonic lavage with warmed polyethylene glycol via the ileostomy and postoperative antegrade instillation of vancomycin flushes into the diseased colon via the ileostomy

PROCEDURE

Total Abdominal Colectomy with end ileostomy

Removal of entire colon with preservation of rectal stump and construction of end ileostomy

Sponsors & Collaborators

• Jewish General Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2019-11-30

Completion

2019-11-30

Countries

• Canada

Study Locations