Surgery vs Medicine for Diverticulitis

(COSMID Trial)

Recruiting at 29 trial locations

Overseen By Giana Davidson, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Immunosuppressants, IBD meds, IBS meds

Disqualifiers: Liver failure, Renal failure, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether surgery or medical management better improves the quality of life for people with diverticulitis, a condition where small bulging pouches in the digestive tract become inflamed or infected. Participants are randomly assigned to either elective surgery to remove the affected part of the colon (partial colectomy) or a medical plan that includes diet changes, exercise, and possibly medications. The trial targets individuals who have experienced at least one episode of diverticulitis confirmed by a scan, with ongoing symptoms or concerns for three months or more after recovery. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance future treatment options for diverticulitis.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications for inflammatory bowel disease or irritable bowel syndrome, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that partial colectomy, which involves removing part of the colon, is generally well-tolerated. Studies have found that a laparoscopic approach, a less invasive method, leads to fewer complications and quicker hospital discharge. In recent years, surgery has resulted in fewer complications, making it a safer option for many.

Conversely, treating diverticulitis with medication has been used for over 30 years and is considered safe. This treatment often includes dietary and exercise changes, fiber supplements, and sometimes medications like mesalazine and probiotics. This approach is well-established, and studies suggest it effectively manages symptoms without serious side effects. Both surgical and medical options have evidence supporting their safety, making them good choices for those considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for diverticulitis because they offer two distinct paths for managing the condition. Partial colectomy is unique because it surgically removes the diseased segment of the colon, potentially preventing future flare-ups by addressing the root cause directly. This procedure is often performed laparoscopically, which can lead to a quicker recovery compared to traditional surgery. On the other hand, medical management provides a comprehensive, non-surgical approach using lifestyle changes and medications like mesalazine and rifamycin, which have shown promise in smaller studies. This option appeals to those who prefer less invasive interventions, offering a personalized regimen that targets symptoms and aims to improve quality of life.

What evidence suggests that this trial's treatments could be effective for diverticulitis?

This trial will compare Partial Colectomy with Medical Management for diverticulitis. Studies have shown that laparoscopic colectomy, a surgery where part of the colon is removed, leads to better outcomes for patients with diverticulitis. This surgery has a low recurrence rate, with only about 2.14% of patients experiencing a return of the condition over 15 years. Most patients do not experience a recurrence after this surgery. Additionally, laparoscopic colectomy typically results in shorter hospital stays and fewer complications compared to traditional open surgery.

In contrast, Medical Management, another treatment option in this trial, involves dietary changes, fiber supplements, and sometimes medications like mesalazine (an anti-inflammatory drug) and probiotics. This approach has been effective for many patients, depending on their specific symptoms and response to treatment. Both surgery and medical management offer benefits, and the choice depends on individual needs and responses. ^{1 6 7 8 9}

Who Is on the Research Team?

David R Flum, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have a history of simple diverticulitis without current symptoms or ongoing issues related to diverticular disease.

Exclusion Criteria

Prior enrollment in the study or other investigational drug or vaccine while on study treatment

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either elective segmental colectomy or best medical management

6 weeks

1 visit (in-person) for surgery, multiple visits for medical management

Follow-up

Participants are monitored for quality of life and symptoms using the GIQLI at 6, 9, and 12 months

12 months

3 visits (in-person or virtual) at 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Medical Management
• Partial Colectomy

Trial Overview

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.

How Is the Trial Designed?

Group I: Partial Colectomy Active Control 1 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 Management Active Control 1 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.

Medical Management is already approved in United States, European Union for the following indications:

Approved in United States as Best Medical Management for:

• Uncomplicated Diverticulitis
• Chronic Diverticular Disease

Approved in European Union as Conservative Management for:

• Uncomplicated Diverticulitis
• Recurrent Diverticulitis
• Chronic Diverticular Disease

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A meta-analysis of 11 studies involving 2676 patients found that observational management of uncomplicated colonic diverticulitis is as effective as antibiotic treatment, with no significant difference in the need for emergency surgery or recurrence rates.

The analysis also showed that oral antibiotics are as effective as intravenous antibiotics for treating diverticulitis, while being more cost-effective, suggesting that less aggressive treatment strategies may be viable options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analyses of Current Strategies to Treat Uncomplicated Diverticulitis. Mege, D., Yeo, H.[2019]

In a study of 70,420 patients undergoing colectomy for diverticulitis, those with significant pre-operative respiratory comorbidities (like COPD and dyspnea) experienced significantly lower odds of mortality and morbidity when treated with laparoscopic surgery compared to open surgery.

Laparoscopic procedures also resulted in a shorter average hospital length of stay (LoS), with reductions of about 4 to 5 days compared to open surgery, highlighting its advantages for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic colectomy for diverticulitis in patients with pre-operative respiratory comorbidity: analysis of post-operative outcomes in the United States from 2005 to 2017. Patel, R., Zagadailov, P., Merchant, AM.[2022]

In a study of 158 patients with right-sided colonic diverticulitis, 85.4% were treated conservatively with antibiotics and bowel rest, showing that this approach is both safe and effective.

The study found no significant differences in clinical outcomes or recurrence rates between patients treated conservatively and those who underwent surgery, suggesting that nonoperative treatment may be the preferred option even in complicated cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of right colonic diverticulitis: the role of nonoperative treatment. Kim, MR., Kye, BH., Kim, HJ., et al.[2021]

Diverticulitis is a major reason for elective colonic surgeries, but there is ongoing debate about how to classify the condition and the best treatment options based on its severity.

There is a growing trend towards treating diverticular disease conservatively, even in more complicated cases, highlighting the need for clearer guidelines on surgical therapy and unanswered questions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective Surgery for Sigmoid Diverticulitis - Indications, Techniques, and Results. Jurowich, CF., Germer, CT.[2020]

Diverticulitis has become a common reason for hospitalizations related to the gastrointestinal tract, with cases ranging from mild to severe, complicated forms.

Recent studies suggest that nonoperative management of diverticulitis may provide outcomes that are equal to or better than traditional aggressive surgical approaches, indicating a shift in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Diverticulitis in 2017. Deery, SE., Hodin, RA.[2018]

Colonic diverticulosis is common in Western countries, especially in older adults, and is usually asymptomatic, but can lead to complications when diverticula become infected and inflamed.

Acute, uncomplicated diverticulitis can often be effectively managed with antibiotics alone, and decisions regarding surgical intervention are made based on individual patient circumstances, reflecting an evolving understanding of the disease's treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diverticulosis and acute diverticulitis. Touzios, JG., Dozois, EJ.[2022]

A study of 14,124 patients in Ontario, Canada, showed a significant decline in elective colectomy rates following nonoperative management of diverticulitis, dropping from 9.6% in 2002 to 3.9% by 2011, particularly among younger patients and those with complicated disease.

The findings suggest a shift in clinical practice towards nonoperative management of diverticulitis, aligning with evolving guidelines, as the odds of undergoing elective surgery decreased by 7% per year after adjusting for patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Decline of Elective Colectomy Following Diverticulitis: A Population-Based Analysis. Li, D., Baxter, NN., McLeod, RS., et al.[2016]

Immunocompromised patients with diverticulitis face significantly higher risks of emergency surgery and postoperative mortality compared to immunocompetent patients, with risk ratios of 1.76 and 3.05, respectively, based on a meta-analysis of 10 studies involving nearly 2 million subjects.

Overall mortality rates are also significantly higher in immunocompromised patients with diverticulitis, indicating a need for enhanced medical treatment and a multidisciplinary approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative outcomes of acute colonic diverticulitis in immunocompromised versus immunocompetent patients: a systematic review and meta-analysis. Lee, JG., Park, YE., Chang, JY., et al.[2023]

In uncomplicated diverticulitis, outpatient treatment with antibiotics is effective for immunocompetent patients, but the benefits of high-fiber diets and certain medications like mesalamine or rifaximin for acute episodes and recurrence prevention are still unclear.

For complicated diverticulitis with abscesses larger than 8 cm, surgery is necessary, and the choice between antibiotic treatment and percutaneous drainage remains controversial, highlighting the need for experienced surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drains, Germs, or Steel: Multidisciplinary Management of Acute Colonic Diverticulitis. Lauro, A., Pozzi, E., Vaccari, S., et al.[2021]

In a study of 86 patients (76 nonimmunocompromised and 10 immunocompromised), medical therapy was successful in 76% of nonimmunocompromised patients, while it failed completely in immunocompromised patients, highlighting the need for a high index of suspicion for diagnosis in this group.

All immunocompromised patients required surgery for acute diverticulitis, with colostomy and resection showing fewer complications compared to colostomy and drainage, suggesting it may be the preferred surgical approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute diverticulitis. Comparison of treatment in immunocompromised and nonimmunocompromised patients. Perkins, JD., Shield, CF., Chang, FC., et al.[2019]

Diverticulitis is a complex condition that requires careful medical management, particularly in challenging cases such as those involving immunocompromised patients or younger individuals.

Current recommendations for treating diverticulitis include specific antibiotic and dietary therapies, but there are potential pitfalls in diagnosis and treatment that healthcare providers must be aware of to avoid mismanagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical treatment of diverticular disease. Welling, DR.[2021]

Diverticulitis is increasingly diagnosed in younger patients under 50, suggesting a shift in the demographic traditionally associated with this condition, and genetic factors may play a larger role than previously understood.

Non-operative management, primarily involving antibiotics and supportive care, is effective for over 70% of patients, while surgical options like segmental colectomy are reserved for severe or recurrent cases, highlighting a more tailored approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the management of sigmoid diverticulitis. Hanna, MH., Kaiser, AM.[2021]

Nonoperative management is effective for treating uncomplicated right colonic diverticulitis, with a low recurrence rate of only 1% among 276 patients treated for inflamed diverticulum or phlegmon.

In contrast, patients with pericolic abscesses had a higher recurrence rate of 20%, indicating that this condition may require more careful management and possibly surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonoperative management of right colonic diverticulitis using radiologic evaluation. Park, HC., Chang, MY., Lee, BH.[2016]

Citations

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The Medical and Nonoperative Treatment of Diverticulitis

The success of medical management for diverticular disease depends on the patient's presentation and degree of response to treatment.

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Elective sigmoid resection is a treatment option for patients with recurrent or persistent painful diverticulitis, as it improves quality of ...

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pmc.ncbi.nlm.nih.gov

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In this study, we investigate the effectiveness of conservative treatment in elderly people after the first episode of complicated diverticulitis. Materials ...

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aafp.org

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Diverticular Disease: Rapid Evidence Review

The current article provides a summary of the best evidence on diagnosis and management of diverticular disease.

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Diverticulitis Treatment & Management

Some studies indicate that nonantibiotic management of acute uncomplicated diverticulitis is safe and feasible. Acute diverticulitis tends to be ...

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The purpose of this Clinical Practice Update is to provide practical and evidence-based advice for management of diverticulitis.

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academic.oup.com

academic.oup.com/bjsopen/article/5/2/zraa073/6246781

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Non-operative management of perforated diverticulitis in those aged less than 65 years is feasible and safe. Reintervention rates following ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2589845024000204

Contemporary management of diverticulitis

For instance, clinicians are beginning to recognize that avoidance of antibiotics in uncomplicated diverticulitis is not associated with worse outcomes.