DiverticulitisNCT01986686
Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
A study testing Colon resection in people with Diverticulitis, run by Stony Brook University at 1 site in United States.
Trial summary
Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Colon resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 16 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- older than or equal to 18
- history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol
- the diagnosis confirmed by colonoscopy
- Signed informed consent
Who cannot join
- Prior episode of diverticulitis
- Right sided diverticulitis
- Failure of recovery from first episode, defined as recurrence within one month.
- Cancer found at the site on screening colonoscopy
- Comorbidities prohibiting surgery (as measured by colorectal POSSUM score)
- Immunosuppressed patients
- Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm)
- Patients who are unable to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.
Read the detailed description
This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
- Conditions
- Diverticulitis
- Being tested
- Colon resection
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon resectionProcedure or surgery
Elective robotic/laparoscopic/open colon resection for diverticular disease.
| Study group | Role | What they receive |
|---|---|---|
| Observational | No intervention | The observation group will be followed clinically with no further intervention until the primary endpoint is reached. |
| Surgery | Active comparator | The surgery group will be offered colon resection. Receives: Procedure: Colon resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Study Endpoint
The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
Measured: Minimum of 1 year after enrollment
Secondary outcomes (5)
Measure Length of Hospital Stay for Surgery vs Non Surgery Patients
Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.
Measured: 4 years
Mortality
Data will be collected on percent of patients who die during the follow-up period after enrollment.
Measured: 4 years
Readmission
Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.
Measured: 30 days
Post Operative Complications
Data will be collected on percent and type of complications for the surgery arm.
Measured: 30 days
Recurrence and Treatment
Data will be collected on recurrence and treatment for recurrent diverticulitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startOct 2011
- Primary completion16 Jul 2016
- Study completion16 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Roberto C Bergamaschi, MD, PhD, Principal investigator, Stonybrook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986686
- Sponsor's protocol ID
- RCB1956
- Status last verified
- May 2017
- First submitted
- 9 Aug 2013
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
You K, Bendl R, Taut C, Sullivan R, Gachabayov M, Bergamaschi R; Study Group on Diverticulitis. Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively. Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23.
PubMed 29683483
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01986686
- Acronym / sponsor ID
- RCB1956
- Conditions
- Diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2011
- Primary completion
- 16 Jul 2016 (actual)
- Study completion
- 16 Jul 2016 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.
Detailed description
This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational | No intervention | –The observation group will be followed clinically with no further intervention until the primary endpoint is reached. |
| Surgery | Active comparator | Procedure: Colon resectionThe surgery group will be offered colon resection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than or equal to 18
- history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol
- the diagnosis confirmed by colonoscopy
- Signed informed consent
Key exclusion criteria (8 listed)
- Prior episode of diverticulitis
- Right sided diverticulitis
- Failure of recovery from first episode, defined as recurrence within one month.
- Cancer found at the site on screening colonoscopy
- Comorbidities prohibiting surgery (as measured by colorectal POSSUM score)
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 |
|---|---|---|
| Colon resectionElective robotic/laparoscopic/open colon resection for diverticular disease. | Procedure or surgery | Surgery |
Primary outcome
Primary Study Endpoint
Time frame: Minimum of 1 year after enrollment
The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
5 secondary outcomes
Measure Length of Hospital Stay for Surgery vs Non Surgery Patients
Time frame: 4 years
Mortality
Time frame: 4 years
Readmission
Time frame: 30 days
Post Operative Complications
Time frame: 30 days
Recurrence and Treatment
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29683483You K, Bendl R, Taut C, Sullivan R, Gachabayov M, Bergamaschi R; Study Group on Diverticulitis. Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively. Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23.
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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.
Roberto C Bergamaschi, MD, PhD principal investigator
Stonybrook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon resection in people with Diverticulitis, run by Stony Brook University 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 8 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 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Study Endpoint (time frame: Minimum of 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986686, which also lists 1 linked publication.
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 Oct 2017.