What side effects are associated with this type of intervention?

Elective colectomy, a common treatment for quality of life-limiting diverticular disease, involves the surgical removal of the diseased portion of the colon. Known side effects and complications of this procedure include infection, bleeding, and anastomotic leak (where the reconnected bowel segments leak). Long-term complications can include bowel dysfunction, such as diarrhea or constipation, and the potential need for additional surgeries. Patients may also experience general surgical risks such as reactions to anesthesia, blood clots, and delayed wound healing.

What prior FDA approvals exist?

The FDA has approved various antibiotics for the treatment of acute diverticulitis, which typically include ciprofloxacin, metronidazole, and amoxicillin-clavulanate. These medications are used to manage infections and inflammation associated with diverticulitis. For chronic or recurrent cases, elective colectomy, which involves the surgical removal of the diseased portion of the colon, is a treatment option being studied for its effectiveness in improving quality of life. This surgical intervention is considered when medical management fails to provide adequate relief or prevent recurrent episodes.

What other types of research exist?

Promising, novel alternatives to elective colectomy for diverticulitis patients include advanced medical management strategies, such as targeted antibiotics, anti-inflammatory medications, and probiotics aimed at reducing inflammation and preventing recurrence. Minimally invasive procedures like percutaneous abscess drainage and laparoscopic lavage are also being explored as less invasive options compared to traditional surgery. These alternatives focus on improving patient outcomes and quality of life while minimizing the need for extensive surgical intervention.

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Surgery vs Medicine for Diverticulitis (COSMID Trial)

N/A

Recruiting

Led By David R Flum, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adults ≥18 years

Must not have

Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, 'frozen abdomen')

Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mean giqli at 6, 9, and 12 months following randomization to treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial compares surgery (removing part of the colon) with a combination of medications and lifestyle changes for patients whose diverticular disease affects their quality of life. It aims to find out which treatment helps these patients feel better and live more comfortably.

Who is the study for?

Adults over 18 with a history of recurrent diverticulitis confirmed by CT and colonoscopy, who are currently symptom-free or have persistent symptoms for more than 3 months after an episode. Not eligible if they have right-sided diverticulitis, take certain medications for bowel diseases, had previous surgeries for diverticulitis, are pregnant or planning to become pregnant soon, or have conditions that rule out surgery.

What is being tested?

The COSMID trial is testing whether elective colectomy (a type of surgery) is more effective than the best medical management in improving quality of life for patients with problematic diverticular disease. Patients will either undergo surgery or receive medical treatment based on random assignment.

What are the potential side effects?

Possible side effects from the surgical intervention may include typical risks associated with operations such as infection, bleeding, and reactions to anesthesia. Medical management could cause side effects related to medication like stomach upset, allergic reactions or other drug-specific issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one confirmed diverticulitis episode and a colonoscopy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like liver or kidney failure that prevent surgery.

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I am on medication for Crohn's disease or ulcerative colitis.

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I have had surgery for diverticulitis before.

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I have a weak immune system due to low neutrophil count, use of immunosuppressive drugs, or AIDS.

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I cannot or do not want to complete follow-up surveys for the study.

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I had surgery in my abdomen or pelvis area within the last month.

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I have had surgery or procedures for fistula, stricture, or bleeding due to diverticular disease.

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I am currently receiving chemotherapy or radiation for cancer.

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I have diverticulitis on the right side of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean giqli at 6, 9, and 12 months following randomization to treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean giqli at 6, 9, and 12 months following randomization to treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean giqli at 6, 9, and 12 months following randomization to treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Partial ColectomyActive Control1 Intervention

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.

Group II: Medical ManagementActive Control1 Intervention

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diverticulitis include medical management and elective colectomy. Elective colectomy involves the surgical removal of the diseased portion of the colon, which directly eliminates the source of inflammation and infection, thereby preventing recurrence and complications. Medical management typically includes antibiotics to treat infection and anti-inflammatory medications to reduce inflammation. While medical management aims to control symptoms and prevent complications, elective colectomy offers a more definitive solution by removing the affected tissue, which can be particularly beneficial for patients with recurrent or severe disease.