DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

NCT ID: NCT02776787

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

418 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-04-30

Brief Summary

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Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients' lives.

Detailed Description

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This study will examine both clinical and non-clinical reasons for pursuing surgery, taking into account previously unexplored areas in surgical decision-making including the comprehensive impact of this disease, as well as factors that impact a surgeon's willingness to recommend surgery. Ultimately, this patient-centered research approach will help us understand the impact of treatment decisions on a patient's quality of life, work, and clinical symptoms, and will ultimately help to inform our recommendations for the treatment of patients with diverticulitis.

The DEBUT study was developed from questions raised by our Washington State Surgical Collaborative, (SCOAP Colon and Rectal Surgery Work Group) and will be carried out in clinics and hospitals across Washington State, Oregon, and California. The investigators invite patients to participate in research activities designed to identify the impact of diverticulitis and treatment options, in order to better understand the outcomes that matter most to patients. Patients who are considering surgery or who have received treatment for their diverticulitis will be recruited for study participation. Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent quarterly for up to four years. These surveys will examine quality of life, overall health, and clinical symptoms to understand what drives patients and surgeons to an operation, as well as how that decision impacts quality of life and recurrent events in patients that choose to have surgery compared to those that do not have surgery. Participating surgeons will complete surveys that examine their indications for surgery and surgical outcomes.

Conditions

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Diverticulitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with diverticulitis

No interventions assigned to this group

Surgeons

Surgeons who perform elective colon resections

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed diagnosis of diverticulitis
* Patients 18 years of age or older
* Patients who are able to consent to participate in research

Exclusion Criteria

* Patients that have had prior colon resection surgery
* Patients that do not make their own medical decisions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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David Flum

Director, Surgical Outcomes Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giana Davidson, MD, MPH

Role: STUDY_DIRECTOR

University of Washington

Locations

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UCLA Ronald Reagan

Los Angeles, California, United States

Site Status

Olive View - UCLA Medical Center

Sylmar, California, United States

Site Status

NYU Langone Health

Brooklyn, New York, United States

Site Status

Legacy Health

Portland, Oregon, United States

Site Status

Skagit Regional Health

Mount Vernon, Washington, United States

Site Status

Valley Medical Center

Renton, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Northwest Hospital and Medical Center

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK103915-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003708

Identifier Type: -

Identifier Source: org_study_id

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