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

September 6, 2023 updated by: David Flum, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kelsey M Pullar, MPH
  • Phone Number: 206 221-8247
  • Email: kpullar@uw.edu

Study Contact Backup

  • Name: Erin E Fannon
  • Phone Number: 206 685-9770
  • Email: ecarney@uw.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
      • San Diego, California, United States, 92103
      • San Francisco, California, United States, 94143
      • Stanford, California, United States, 94305
    • Colorado
    • Florida
      • Gainesville, Florida, United States, 32608
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Evanston, Illinois, United States, 60201
      • Springfield, Illinois, United States, 62794
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Burlington, Massachusetts, United States, 01805
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
      • Flushing, New York, United States, 11355
        • Recruiting
        • New York Presbyterian-Queens
        • Contact:
      • New York, New York, United States, 10027
      • Rochester, New York, United States, 14618
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel Health Systems
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Virginia
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98101
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Mean GIQLI at 6, 9, and 12 months following randomization to treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: David R Flum, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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