Clostridium Difficile ColitisNCT01441271
Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis
A study testing Ileal diversion and lavage and total abdominal colectomy in people with Clostridium Difficile Colitis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Colitis
- What is being tested?
- Ileal diversion and lavage and total abdominal colectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
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.
Read the 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.
- Conditions
- Clostridium Difficile Colitis
- Being tested
- Ileal diversion and lavage, total abdominal colectomy
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal diversion and lavageProcedure or surgery
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.
total abdominal colectomyProcedure or surgery
Also called subtotal 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.
| Study group | Role | What they receive |
|---|---|---|
| total abdominal colectomy | Active comparator | the standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy Receives: 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. Receives: Procedure: Ileal diversion and lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Both groups will be compared using mortality as the primary outcome.
Measured: 28 day
Secondary outcomes (4)
ICU Length of Stay (LOS
14 days
Measured: during hospitalization
Hospital LOS
1 year
Measured: hospitalization
ventilation days
1 year
Measured: while in ICU
morbidity
1 year
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionSep 2013
Why it stopped: Numer of eligible patients markedly decreased since the initiation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile ColitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc A. de Moya, Massachusetts General Hospital
- Investigators
- Marc de Moya, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441271
- Sponsor's protocol ID
- 2012-P-000138/1; MGH
- Status last verified
- Apr 2015
- First submitted
- 17 Sep 2011
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01441271
- Acronym / sponsor ID
- 2012-P-000138/1; MGH
- Conditions
- Clostridium Difficile Colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Numer of eligible patients markedly decreased since the initiation of the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total abdominal colectomy | Active comparator | Procedure: total abdominal colectomythe standard of care for fulminant clostridium difficile colitis is a total abdominal colectomy |
| Ileal diversion and lavage | Experimental | Procedure: Ileal diversion and lavageThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ileal diversion and lavageThe 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 or surgery | Ileal diversion and lavage |
| total abdominal colectomyAlso: subtotal colectomyThe 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. | Procedure or surgery | total abdominal colectomy |
Primary outcome
Mortality
Time frame: 28 day
Both groups will be compared using mortality as the primary outcome.
4 secondary outcomes
ICU Length of Stay (LOS
Time frame: during hospitalization
Hospital LOS
Time frame: hospitalization
ventilation days
Time frame: while in ICU
morbidity
Time frame: during hospitalization
Results and safety
The study was stopped early (reason given: Numer of eligible patients markedly decreased since the initiation of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc de Moya, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal diversion and lavage and total abdominal colectomy in people with Clostridium Difficile Colitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Numer of eligible patients markedly decreased since the initiation of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.