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Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (COSMID)

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ClinicalTrials.gov Identifier: NCT04095663
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
David Flum, University of Washington

Brief Summary:
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm.

Condition or disease Intervention/treatment Phase
Diverticulitis Procedure: Partial Colectomy Other: Medical Management Not Applicable

Detailed Description:

For over 50 years, professional society recommendations for the management of uncomplicated diverticulitis included early elective surgery to prevent the need for an emergency operation and avoid the risk of colostomy. Over the last 15 years the notion that a patient must have a certain number of episodes of acute uncomplicated diverticulitis (AUD) before undergoing elective colectomy has changed dramatically. This was, in part, due to studies showing that emergency surgery for complicated disease is much more likely to be needed during the first episode of diverticulitis, making the notion of prophylactic elective colectomy for AUD less relevant. Furthermore, clinicians realized that most recurrent episodes of AUD could be managed with outpatient antibiotics alone and that "best medical management" - including fiber supplementation, mesalazine, rifamycin and probiotics - could reduce symptoms between episodes of AUD. All of the components of best medical management have some, albeit limited, evidence of effectiveness, most in improving symptoms rather than reducing the risk of recurrence and are relatively safe and inexpensive. Best medical management is far less invasive than elective surgery but infrequently prescribed the US, in part because of limited insurance coverage. Alternatively, resection removes the diseased segment of colon, does relieve symptoms and decreases the risk of recurrence.

In 2014, guidelines from the American Society of Colorectal Surgeons (ASCRS) abandoned "episode count" as an indication for surgery in patients with AUD and instead recommended individualizing the decision to operate for AUD based on the "effects on lifestyle (professional and personal) of recurrent attacks". Decision making about surgery in patients with lingering symptoms after recovery from an episode of AUD has not been the specific focus of an ASCRS guideline, but recommendations about elective surgery emphasize individualizing decision making based on the overall impact of the disease on the patient.These recommendations for individualization of treatment based on the quality of life (QoL) impact of recurrent AUD and lingering symptoms highlight the decision that hundreds of thousands of people now have to make each year. Based on the effect of the disease on their QoL they must choose between two very different treatment options: elective colectomy vs. best medical management. While the recommendation to individualize treatment based on the QoL impact is a step forward in advancing patient-centered care, the comparative effectiveness of these two treatments on symptoms and QoL has not been well studied.

This will be a multi-site, open randomized trial in which participants with either recurrent AUD or lingering symptoms after an episode of AUD are randomized to one of two initial treatment strategies, elective segmental colectomy (performed laparoscopically when possible) and best medical management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Partial Colectomy
Elective segmental colectomy for diverticular disease involves removal of the segment of colon (most commonly sigmoid and/or left colon) where there has been disease identified by computed tomography imaging or colonoscopy. Elective colectomy usually removes the affected colon along with adjacent segments that have diverticula, with a primary anastomosis performed to reestablish bowel continuity. Most surgeons now perform the procedure using a laparoscopic approach, when possible, and sometimes use a temporary, protective stoma if the re-connection is considered high-risk. The technique for laparoscopic resection is not specified by the protocol (allows for any number of laparoscopic port sites, all incision types, hand-assistance and robotic) with details of the technique recorded. If randomized to elective colectomy, patients will be encouraged to undergo the procedure within 6 weeks of assignment.
Procedure: Partial Colectomy
Most partial colectomies are performed using a laparoscopic approach, when possible, and surgeons sometimes use a temporary, protective stoma if the re-connection is considered high risk.

Active Comparator: Medical Management
Medical management for diverticular disease has been used for over 30 years and includes a set of interventions, all components of which have been the subject of small, but often positive trials. All patients randomized to medical management or who select it as their treatment in the observational cohort will view a video (provided in English and Spanish) that explains each element of the medical management "toolbox": diet and exercise recommendations, fiber supplementation (e.g., augmenting dietary fiber or over the counter fiber supplements), with mesalazine tablets or suppositories, probiotics and rifamycin. In consultation with their physician, they will be recommended to a regimen of diet and exercise and fiber supplementation. Clinicians will be asked to consider rifamycin (dose/frequency) for those with AUD who are not responding to diet and exercise and mesalazine (dose/frequency) for those with lingering symptoms who are not responding to diet and exercise.
Other: Medical Management
Patients will be offered a varying combination of tools from the best medical management "toolbox" (diet and exercise, fiber supplementation/probiotics, and rifamycin/mesalazine) depending on what they have already tried. Based on the "evidence-based best medical toolbox" clinicians will be asked to consider rifamycin (dose/frequency) for those with AUD who are not responding to diet and exercise and mesalazine (dose/frequency) for those with lingering symptoms who are not responding to diet and exercise.




Primary Outcome Measures :
  1. Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: Mean GIQLI at 6, 9, and 12 months following randomization to treatment ]
    The primary outcome of mean GIQLI at 6, 9, and 12 months will be assessed using an ANCOVA regression model that adjusts for an indicator of randomized treatment group, the GIQLI score as measured at baseline prior to randomization, as well as factors used to stratify randomization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults ≥18 years
  2. At least one episode of diverticulitis confirmed by CT scan in last 5 years and a colonoscopy to rule out or screen for other colon pathology concordant with screening guidelines; AND A. History of recurrent uncomplicated diverticulitis without current symptoms (AUD in remission) over the prior 5 years; OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)

Exclusion Criteria:

  1. Unable or unwilling to return or be contacted for and/or complete research surveys;
  2. Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
  3. Previous operation for diverticulitis
  4. Current diagnosis or previous endoscopic or surgical interventions for bleeding, fistula, stricture related to diverticular disease.
  5. Right-sided diverticulitis
  6. Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
  7. Actively undergoing chemotherapy or radiation for malignancy
  8. Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs (e.g., oral corticosteroids, anti-TNF agents), or known AIDS [i.e., recent CD4 count <200 ] assessed by patient history);
  9. Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
  10. Taking prescription medication for irritable bowel syndrome;
  11. Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
  12. Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
  13. Abdominal/pelvic surgery in the past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095663


Contacts
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Contact: Kelsey M Pullar, MPH 206 221-8247 kpullar@uw.edu
Contact: Erin E Fannon 206 685-9770 ecarney@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Alex Ruiz    206-221-3883    aruiz06@uw.edu   
Contact: Kelsey Pullar, MPH    206.221.8247    kpullar@uw.edu   
Principal Investigator: Giana Davidson, MD MPH         
Sponsors and Collaborators
University of Washington
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: David R Flum, MD University of Washington
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Responsible Party: David Flum, Professor, School of Medicine: Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT04095663    
Other Study ID Numbers: STUDY00007409
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases