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

March 20, 2024 updated by: Niguarda Hospital

Prospective Evaluation of Quality of Life in Patients With Acute Colonic Diverticular Disease: Diverticular Disease Registry DDR Trial

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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 Demographic and functional data will be recorded during the first surgical visit, together with a complete clinical examination. Data regarding the symptoms of presentation and quality of life will be collected and categorized. Comorbidity Index adjusted for age will be calculated for every patient, while those >70 years old will be assessed for frailty risk using the modified Frailty Index (mFI) described by Robinson et al. Relevant medications will be listed.

Setting, (emergency room vs outpatients clinic), need for admission, treatment, emergency surgery vs delayed elective surgery vs only medical management (including percutaneous drain placement) will be recorded.

Intraoperative parameters will be recorded in the registry both for emergency procedures and elective procedures, including several technical aspects such as level of inferior mesenteric artery ligtion, type of energy device used, number and type of stapler cartridge, size of circular stapler,. Use of the laparoscopy technique, conversion rate, peritoneal lavage, surgical second look will be recorded.

Histopathological examination will be recorded in terms of length of the specimen, the presence of microscopic or macroscopic abscesses, the presence of Crohn's like reaction or of lymphocyte infiltration and the eventual presence of unknown cancer.

Post-operative complications will be reported according to the Clavien-Dindo classification 15. Length of stay and post-discharge complications will be evaluated and recorded. Application of Enhanced recovery protocols will be considered only for at least 80% of the designed colo-rectal items will be satisfied.

One investigator in each center will be responsible for the follow up data. Functional follow up will be done yearly according to the GIQLY, FSFI, IIEF, ICIQ, IPSS questionnaires.

Data will be prospectively collected using a REDCAP database by the site principal investigator for each hospital. Quarterly meetings will be set between the study coordinators and the participating centers. A data manager (GP) will regularly control the quality of the data provided

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20162
        • ASST GOM Niguarda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • < 18 yo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
QoL assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gastrointestinal Quality of Life Index (GIQLI)
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Investigators

  • Principal Investigator: Giovanni Ferrari, MD, ASST GOM Niguarda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233-22042021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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