Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 255
- 试验地点
- 51
- 主要终点
- Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years
- •At least one episode of diverticulitis confirmed by CT scan and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology concordant with screening guidelines
- •Persistent signs, symptoms, or concerns related to diverticulitis after recovery from an episode of left-sided diverticulitis as confirmed with self-reported QoL limitation.
排除标准
- •Unable to consent in English or Spanish
- •Current diagnosis or previous endoscopic or surgical interventions for fistula, or stricture or current significant bleeding, related to diverticular disease
- •Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place)
- •Previous operation for diverticulitis
- •Right-sided diverticulitis
- •Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs like oral corticosteroids, anti-TNF agents, or known AIDS [i.e., recent CD4 count <200] assessed by patient history)
- •Actively undergoing chemotherapy or radiation for malignancy
- •Expectant or concurrent hemodialysis, peritoneal dialysis, treatments using indwelling venous catheters, or conditions putting patient at risk for bacterial seeding
- •Diagnosis of inflammatory bowel disease (i.e., Crohn's, ulcerative colitis)
- •Taking prescription medication for irritable bowel syndrome
- •Intolerance or allergy to all medications in the medical management arm
- •Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen") as determined by surgeon
- •Abdominal/pelvic surgery within the past month
- •Pregnant or expecting to become pregnant in the 30 days following baseline/screening
- •Unable to consent to research or self-respond to follow-up surveys (e.g., altered mental status)
- •Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening
- •Prior enrollment in the COSMID study or planning on enrollment in another investigational drug or vaccine while on study treatment
- •Unable or unwilling to return or be contacted for and/or complete research surveys.
研究组 & 干预措施
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.
干预措施: Partial Colectomy (Procedure)
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.
干预措施: Medical Management (Other)
结局指标
主要结局
Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)
时间窗: Mean GIQLI at 6, 9, and 12 months following randomization to treatment
A 36-item questionnaire assessing 5 domains: GI symptoms, physical function, emotional well-being, social well-being, and perception of medical treatment measured by a single item question. Each item has 5 response choices (i.e., all of the time, most of the time, some of the time, a little of the time, never). In addition, the measure produces an overall quality of life score (0-144) where higher numbers indicate greater QoL.
次要结局
- Diverticulitis Quality of Life (DV-QoL) instrument(Baseline, 12 months, 24 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure(Baseline; 6, 12, 24, 36 months)
- Decision Regret Scale(6 and 36 months)
- Work Productivity and Activity Impairment instrument(Baseline; 6, 12, 18, 24, 30, 36 months)
研究者
David Flum
Professor, School of Medicine: Surgery
University of Washington