Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04095663
Study type Interventional
Source University of Washington
Contact Kelsey M Pullar, MPH
Phone 206 221-8247
Email kpullar@uw.edu
Status Recruiting
Phase N/A
Start date October 1, 2019
Completion date January 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01081054 - Hospitalization or Ambulatory Treatment of Acute Diverticulitis Phase 4
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT03337984 - Damage Control Surgery in the Treatment of Complicated Diverticulitis
Recruiting NCT06210724 - FIT in Diverticulitis
Completed NCT01986686 - Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis N/A
Completed NCT01477190 - Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program Phase 1/Phase 2
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Enrolling by invitation NCT03700593 - Feasibility and Safety of Single Port Robot in Colorectal Procedures
Completed NCT00545740 - Prevention of Recurrence of Diverticulitis Phase 3
Recruiting NCT01837342 - Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery N/A
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT00554099 - Asacol Acute Diverticulitis(DIVA)Study Phase 2
Completed NCT04173182 - Confocal Laser Endomicrospy in Colonic Diverticular Disease
Completed NCT02200055 - Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need N/A
Completed NCT01560377 - Perfusion Assessment in Laparoscopic Left Anterior Resection Phase 1