The COLD2B Multicenter, Two-arm Prospective Cohort Study (COLD2B)

April 27, 2024 updated by: Alessio Giordano, Azienda Sanitaria di Firenze

Conservative vs Surgical (Either Open or Laparoscopic) Approach in the Emergency Management of Acute Diverticulitis WSES 2B: the COLD2B Multicenter, Two-arm Prospective Cohort Study

Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, the COLD2B study has been launched to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.

The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).

Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).

The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The COLD2B study is a national, multi-center, prospective observational study of acutely (unplanned and non-elective presentation to hospital for urgent or emergency reasons) presenting patients to the emergency departments of the participating centers with WSES 2b AD (Distant gas - more than 5 cm from inflamed bowel segment).

The study population includes all consecutive adult patients (≥18 years of age) acutely (unplanned and non-elective presentation to hospital for urgent or emergency reasons) presenting at the participating centers with a clinical and radiological diagnosis of WSES 2b AD for 1 year. According to the different management methods, the cohort will be divided into the following categories:

  1. Conservatively treated, which will include patients treated with medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage) and
  2. Surgically resected, which will be devised into the following sub-categories:

2a) Open surgery management, i.e. traditional open surgery approach with any kind of technique: either reconstructive (with or without ileal/colonic stoma protection) or non-reconstructive (see Hartman procedure) 2b) Laparoscopic approach, i.e. emergency laparoscopic resection with the characteristics mentioned above The enrollment period and the overall evaluation will last approximately 1 year.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy
        • Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari
        • Contact:
          • Francesco Paolo Prete
      • Florence, Italy, 50134
        • Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy
        • Contact:
        • Principal Investigator:
          • Carlo Bergamini
        • Principal Investigator:
          • Alessio Giordano
      • Trieste, Italy
        • Department of Medicine, Surgery and Health Sciences, University of Trieste
        • Contact:
          • Manuela Mastronardi
      • Vittorio Veneto, Italy
        • Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana
        • Contact:
          • Giulia Montori

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients affected by WSES 2b acute diverticulitis actively present at participating hospitals

Description

Inclusion Criteria:

  1. Patients of both sexes, ≥ 18 years old.

  2. Patients with abdominal CT scan diagnosis of colonic Acute Diverticulitis classifiable as WSES 2B, i.e..

    1. thickening and other phlegmon signs of the left-sided colonic wall (mostly sigmoid) associated with the inflammatory involvement of the surrounding tissues, plus
    2. presence of air bubbles distant more than 5 cm from the primary colonic inflammatory localization, plus
    3. absence of conspicuous free fluid collection or pelvic abscess.
  3. Patients fit for surgery.
  4. Patients with colonic diverticulitis on postoperative histological examination.

Exclusion Criteria:

  1. Right-sided or transverse diverticulitis
  2. Concomitant bowel abscess, perforation, or fistula
  3. Radiological drainage
  4. Elective procedures.
  5. Pregnancy or lactation
  6. Patients of both sexes, younger than 18 years of age

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
Patients with WSES stage 2b acute diverticulitis
Patients with WSES stage 2b acute diverticulitis on the left or sigmoid colon acutely presenting to the emergency departments of the participating centers
Other: Conservative treatment (non-operative treatment)
Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage)
Other: Surgical treatment (operative treatment)

Surgical treatment (operative treatment) is explained as follows:

  1. Open surgery management, i.e. traditional open surgery approach with any kind of technique: either reconstructive (with or without ileal/colonic stoma protection) or non-reconstructive (see Hartman procedure)
  2. Laparoscopic approach, i.e. emergency laparoscopic resection with the characteristics mentioned above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay in the overall population
Time Frame: 1 year
To develop a predictive model for the length of hospital stay (measured in days) taking into account the treatment received in the overall population
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rate for both arms
Time Frame: 1 year
To compare morbidity (i.e. medical problems related to the treatment) for both conservative and surgical arms
1 year
Mortality rate for both arms
Time Frame: 1 year
to compare mortality for both conservative and surgical arms
1 year
Surgical complications rate
Time Frame: 1 year
To compare surgical complications rate for the surgical arms (laparoscopy versus open), measured according to Clavien-Dindo Classification (grade 1 to 5)
1 year

Collaborators and Investigators

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

Sponsor

Azienda Sanitaria di Firenze

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

  • undefined

Helpful Links

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 20, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carlo Bergamini

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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