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

Primary Purpose

Diverticulitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partial Colectomy
Medical Management
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults ≥18 years
  2. At least one episode of diverticulitis confirmed by CT scan (or pending confirmation) and a colonoscopy (completed or scheduled) 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); 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 fistula or stricture or current significant bleeding 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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting
  • UC San Diego HealthRecruiting
  • UCSF HealthRecruiting
  • Stanford University Medical CenterRecruiting
  • University of ColoradoRecruiting
  • University of FloridaRecruiting
  • University of South FloridaRecruiting
  • Memorial Health University Medical CenterRecruiting
  • Rush University Medical CenterRecruiting
  • Northwestern UniversityRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • University of Iowa HealthcareRecruiting
  • Boston University Medical CenterRecruiting
  • Lahey ClinicRecruiting
  • Albany Medical CollegeRecruiting
  • New York Presbyterian-QueensRecruiting
  • Columbia University Medical CenterRecruiting
  • University of Rochester Medical CenterRecruiting
  • Atrium Health-Carolinas Medical CenterRecruiting
  • Mount Carmel Health SystemsRecruiting
  • Penn MedicineRecruiting
  • Allegheny-Singer Research InstituteRecruiting
  • Medical University of South CarolinaRecruiting
  • UT Southwestern Medical CenterRecruiting
  • University of Utah HealthRecruiting
  • VCU Medical CenterRecruiting
  • Benaroya Research Institute at Virginia MasonRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Partial Colectomy

Medical Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)
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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2019
Last Updated
September 6, 2023
Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04095663
Brief Title
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Acronym
COSMID
Official Title
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial Colectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Medical Management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Partial Colectomy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Medical Management
Intervention Description
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 Measure Information:
Title
Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)
Description
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.
Time Frame
Mean GIQLI at 6, 9, and 12 months following randomization to treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥18 years At least one episode of diverticulitis confirmed by CT scan (or pending confirmation) and a colonoscopy (completed or scheduled) 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); 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: Unable or unwilling to return or be contacted for and/or complete research surveys; Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening; Previous operation for diverticulitis Current diagnosis or previous endoscopic or surgical interventions for fistula or stricture or current significant bleeding related to diverticular disease. Right-sided diverticulitis Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen") Actively undergoing chemotherapy or radiation for malignancy 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); Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis); Taking prescription medication for irritable bowel syndrome; Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening; Prior enrollment in the study or other investigational drug or vaccine while on study treatment; Abdominal/pelvic surgery in the past month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey M Pullar, MPH
Phone
206 221-8247
Email
kpullar@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin E Fannon
Phone
206 685-9770
Email
ecarney@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Flum, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayane Ovsepyan
Email
Gayane.Ovsepyan@cshs.org
Facility Name
UC San Diego Health
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deyna Arellano
Email
daarellano@health.ucsd.edu
Facility Name
UCSF Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Broering
Email
Jenny.Broering@ucsf.edu
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Davis
Email
kdavis3@stanford.edu
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey MacDermott
Email
Tracey.MacDermott@ucdenver.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Bouton
Email
Amber.Bouton@surgery.ufl.edu
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avennette Pinto
Email
apinto3@usf.edu
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alta Castellino
Email
Alta.Castellino@hcahealthcare.com
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Johnson
Email
Matthew_johnson@rush.edu
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rose Arrieta
Email
rarrieta@northwestern.edu
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Mottershaw
Email
kmottershaw33@siumed.edu
Facility Name
University of Iowa Healthcare
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Danielson
Email
jessica-danielson@uiowa.edu
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Malikova
Email
Marina.Malikova@bmc.org
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cody Munroe
Email
cody.munroe@lahey.org
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Belenchia
Email
belencr@amc.edu
Facility Name
New York Presbyterian-Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Ingenito
Email
sui9006@nyp.org
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherene Ishtihar
Email
si2271@cumc.columbia.edu
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Marianetti
Email
Ila_Marianetti@URMC.Rochester.edu
Facility Name
Atrium Health-Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colie Kaiser
Email
nicole.kaiser@atriumhealth.org
Facility Name
Mount Carmel Health Systems
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Brooks
Email
sbrooks2@mchs.com
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allie Raevsky
Email
Allie.Raevsky@Pennmedicine.upenn.edu
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Reading
Email
rachel.reading@ahn.org
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Koren
Email
korenn@musc.edu
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Merriam
Email
mariah.merriam@utsouthwestern.edu
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Esplin
Email
jordan.esplin@hsc.utah.edu
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinfeng Han
Email
jinfeng.han@vcuhealth.org
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Merz
Email
Audrey.Merz@virginiamason.org
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Ruiz
Phone
206-221-3883
Email
aruiz06@uw.edu
First Name & Middle Initial & Last Name & Degree
Kelsey Pullar, MPH
Phone
206.221.8247
Email
kpullar@uw.edu

12. IPD Sharing Statement

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

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