Uncomplicated Diverticular DiseaseMUDNCT03146091
Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment
A study testing Nonantibiotic treatment of uncomplicated diverticulitis and Antibiotic treatment of uncomplicated diverticulitis in people with Uncomplicated Diverticular Disease, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Uncomplicated Diverticular Disease
- What is being tested?
- Nonantibiotic treatment of uncomplicated diverticulitis and Antibiotic treatment of uncomplicated diverticulitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2017to 30 Dec 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 90 years old
- Capable of giving informed consent
- Lower abdominal pain and/or tenderness
- Confirmed affection of left colon, including descending and sigmoid colon
- Confirmed episode of acute uncomplicated diverticulitis on computed tomography (CT) scan defined as wall edema with or without fat stranding. Limited pericolic air with bubbles less than 5 mm in size, and less than 5cm from the colon wall, will be included as uncomplicated diverticulitis. Scan must be performed prior to enrollment and assessment for illegibility. The initial scan is not a study-specific procedure.
Who cannot join
- CT scan shows complicated diverticulitis as defined by the presence of intraperitoneal free perforation (i.e. intraperitoneal contrast extravasation if intra-rectal contrast given, free air under diaphragms, disseminated intraperitoneal air), abscess, obstruction, fistulisation, and phlegmon.
- Suspicion of colorectal cancer on CT scan
- Immunosuppression (including but not exclusively insulin-dependent diabetes mellitus, chronic liver disease, ongoing chemotherapy, chronic renal failure with hemodialysis, corticosteroid and immunosuppressive medication)
- Pregnancy and breastfeeding
- Any comorbid infection requiring
- High fever (≥ 38.5 ºC)
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- Significant leukocytosis (> 15 g/dL)
- Abdominal pain worsening in the emergency, impeding ambulation and/or eating
- Evidence of generalized peritonitis on physical exam
- Intolerance to oral intake and/or persistent vomiting
- Marked abdominal distension and/or signs of ileus on CT scan
- Noncompliance/unreliability for return visits/lack of support system
- Failed outpatient treatment not previously included in study within last 30 days
- Cognitive, social or psychiatric impairment
- For patients aged 65 years or older, a Charlson Comorbidity Score ≥ 5 as calculated on the following website: https://www.thecalculator.co/health/Charlson-Comorbidity-Index-(CCI)-Calculator-765.html 19-20.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment: a Randomized Pilot Trial
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are associated with non-negligible risks to patients. The aim of this trial is to assess the feasibility of a randomized controlled trial designed to determine whether nonantibiotic treatment of uncomplicated diverticulitis is safe in the outpatient setting.
Read the detailed description
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are associated with non-negligible risks to patients. The aim of this trial is to assess the feasibility of a randomized controlled trial designed to determine whether nonantibiotic treatment of uncomplicated diverticulitis is safe in the outpatient setting. It is designed as a pilot non-inferiority blinded randomized controlled trial. The estimated length of this pilot trial is 1 year. The target population is capable adults of who have a CT-diagnosed episode of uncomplicated diverticulitis who present to the Jewish General Hospital Emergency room.
- Conditions
- Uncomplicated Diverticular Disease
- Being tested
- Nonantibiotic treatment of uncomplicated diverticulitis, Antibiotic treatment of uncomplicated diverticulitis
- Keywords
- Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonantibiotic treatment of uncomplicated diverticulitisOther
Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
Antibiotic treatment of uncomplicated diverticulitisOther
Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient nonantibiotic treatment | Experimental | Not described Receives: Other: Nonantibiotic treatment of uncomplicated diverticulitis |
| Outpatient antibiotic treatment | Active comparator | Not described Receives: Other: Antibiotic treatment of uncomplicated diverticulitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up.
The primary outcome pertains to the feasibility of a non-inferiority randomized controlled trial. The study group's main concern is that accrual will be impeded by the important change in clinical management that nonantibiotic treatment of uncomplicated diverticulitis requires. Also, the study group is concerned that patients may be lost to follow-up. For these reasons, the primary outcome is the retention rate of patients from screening to the end of follow-up. The rate will be calculated according to (1) the proportion of participants screened but not randomized, and (2) the proportion of participants lost to follow-up.
Measured: 1 year
Secondary outcomes (1)
Treatment failure
Treatment failure is defined as persistence, increase or recurrence of abdominal pain and/or fever, inflammatory bowel obstruction, need for radiological abscess drainage or immediate surgery due to complicated diverticulitis, need for hospital admission, and mortality during the first 60 days after discharge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start20 May 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Diverticular DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marylise Boutros, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146091
- Sponsor's protocol ID
- CODIM-MBM-17-020
- Acronym
- MUD
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2017
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT03146091
- Acronym / sponsor ID
- MUD / CODIM-MBM-17-020
- Conditions
- Uncomplicated Diverticular Disease
- Keywords
- Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are associated with non-negligible risks to patients. The aim of this trial is to assess the feasibility of a randomized controlled trial designed to determine whether nonantibiotic treatment of uncomplicated diverticulitis is safe in the outpatient setting.
Detailed description
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are associated with non-negligible risks to patients. The aim of this trial is to assess the feasibility of a randomized controlled trial designed to determine whether nonantibiotic treatment of uncomplicated diverticulitis is safe in the outpatient setting. It is designed as a pilot non-inferiority blinded randomized controlled trial. The estimated length of this pilot trial is 1 year. The target population is capable adults of who have a CT-diagnosed episode of uncomplicated diverticulitis who present to the Jewish General Hospital Emergency room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient nonantibiotic treatment | Experimental | Other: Nonantibiotic treatment of uncomplicated diverticulitis |
| Outpatient antibiotic treatment | Active comparator | Other: Antibiotic treatment of uncomplicated diverticulitis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and < 90 years old
- Capable of giving informed consent
- Lower abdominal pain and/or tenderness
- Confirmed affection of left colon, including descending and sigmoid colon
- Confirmed episode of acute uncomplicated diverticulitis on computed tomography (CT) scan defined as wall edema with or without fat stranding. Limited pericolic air with bubbles less than 5 mm in size, and less than 5cm from the colon wall, will be included as uncomplicated diverticulitis. Scan must be performed prior to enrollment and assessment for illegibility. The initial scan is not a study-specific procedure.
Key exclusion criteria (15 listed)
- CT scan shows complicated diverticulitis as defined by the presence of intraperitoneal free perforation (i.e. intraperitoneal contrast extravasation if intra-rectal contrast given, free air under diaphragms, disseminated intraperitoneal air), abscess, obstruction, fistulisation, and phlegmon.
- Suspicion of colorectal cancer on CT scan
- Immunosuppression (including but not exclusively insulin-dependent diabetes mellitus, chronic liver disease, ongoing chemotherapy, chronic renal failure with hemodialysis, corticosteroid and immunosuppressive medication)
- Pregnancy and breastfeeding
- Any comorbid infection requiring
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 |
|---|---|---|
| Nonantibiotic treatment of uncomplicated diverticulitisPatients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol. | Other | Outpatient nonantibiotic treatment |
| Antibiotic treatment of uncomplicated diverticulitisPatients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol. | Other | Outpatient antibiotic treatment |
Primary outcome
Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up.
Time frame: 1 year
The primary outcome pertains to the feasibility of a non-inferiority randomized controlled trial. The study group's main concern is that accrual will be impeded by the important change in clinical management that nonantibiotic treatment of uncomplicated diverticulitis requires. Also, the study group is concerned that patients may be lost to follow-up. For these reasons, the primary outcome is the retention rate of patients from screening to the end of follow-up. The rate will be calculated according to (1) the proportion of participants screened but not randomized, and (2) the proportion of participants lost to follow-up.
1 secondary outcome
Treatment failure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonantibiotic treatment of uncomplicated diverticulitis and Antibiotic treatment of uncomplicated diverticulitis in people with Uncomplicated Diverticular Disease, run by Jewish General Hospital at 1 site in Canada.
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 18 Aug 2022. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up. (time frame: 1 year). 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 18 Aug 2022.