Prospective Evaluation of Quality of Life in Patients With Acute Colonic Diverticular Disease

NCT04907383 | Terminated

• 1 other identifier: 233-22042021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter prospective observational study. Aim of the study is to identify the clinical parameters correlating with favorable outcomes in patients undergoing surgery or medical treatment for diverticular disease. The primary aim is be the assessment of quality of life of theses patients according to the GIQLY score at 1 year from the enrollment in the registry. Patients will be enrolled in a prospective study and followed for 36 months after the diagnosis of acute diverticulitis. All participating centres are tertiary hospitals located in Europe .

Conditions

Colonic Diverticulitis

Keywords

Diverticular disease; Acute diverticulitis; Emergency surgery; Prospective observational study

Outcome Measures

Primary Outcomes (1)

• The Gastrointestinal Quality of Life Index (GIQLI)

  The primary aim is the assessment of the quality of life of these patients according to the GIQLI score at 1 year from the enrollment in the study. The GIQLI5 is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.

  1 year

Study Arms (1)

Diverticular disease

All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection. Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged \> 18 years old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible

Other: quality of life

Interventions

quality of life OTHER

QoL assessment

Diverticular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection. All patients diagnosed with left-side colonic diverticulitis who are treated in one of the participating hospitals will be asked to participate in this cohort study. The sample size will be that obtained at the end of the 5 years of recruitment. From January 2010 to December 2019, a mean number of 26 patients per year have been operated on for diverticular disease among each of the centers involved in the study. Thus, giving a total recruiting capacity of 78 patients per year, nearly 400 patients are expected to be enrolled in a 5 years' time period.

You may qualify if:

• imaging-proven colonic diverticular disease
• patient aged \> 18 years old
• Written informed consent obtained
• A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible
• Patients undergoing surgical or medical treatment will be enrolled in the registry and undergo a 36-months follow up period.

You may not qualify if:

• \< 18 yo

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

Location

Related Publications (1)

• Origi M, Achilli P, Calini G, Costanzi A, Monteleone M, Montroni I, Maggioni D, Cocozza E, Megna S, Totis M, Tamini N, Ziccarelli A, Filippone G, Ferrari G, Crippa J, Spinelli A, Mari GM; AIMS Academy Clinical Research Network. The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study. Int J Surg Protoc. 2021 Aug 30;25(1):194-200. doi: 10.29337/ijsp.157. eCollection 2021.

  PMID: 34541429 DERIVED

MeSH Terms

Conditions

Diverticulitis, Colonic; Diverticular Diseases

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Diverticulitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Giovanni Ferrari, MD

  ASST GOM Niguarda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)