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

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.

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Ronald Reagan, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL)

Time frame: 3 months - 4 years

Patient-reported burden of disease (diverticulitis symptoms and quality of life, as measured by the Diverticulitis Quality of Life scale (DV-QOL)) will be measured over time among patients that do and do not undergo elective colon resection.

Secondary outcomes

Number of patients who report non-clinical factors as reason for deciding to have surgery

Time frame: 3 months - 4 years

Patient-reported factors (clinical and non-clinical) for deciding to have elective colon surgery, or deciding to have medical management for diverticulitis will be analyzed across surgical and non-surgical patients.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Acronym: DEBUT

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2022
First posted: May 18, 2016
Registry last updated: Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed