The COLD2B Multicenter, Two-arm Prospective Cohort Study

Not yet recruiting

• Conditions: Acute Diverticulitis
• Interventions: Other: Conservative treatment (non-operative treatment); Other: Surgical treatment (operative treatment)

• Registration Number: NCT06388538
• Lead Sponsor: Azienda Sanitaria di Firenze

Brief Summary

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).

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-30
• Study Start: 2024-06-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with WSES stage 2b acute diverticulitis	Conservative treatment (non-operative treatment)	Patients with WSES stage 2b acute diverticulitis on the left or sigmoid colon acutely presenting to the emergency departments of the participating centers
Patients with WSES stage 2b acute diverticulitis	Surgical treatment (operative treatment)	Patients with WSES stage 2b acute diverticulitis on the left or sigmoid colon acutely presenting to the emergency departments of the participating centers

Primary Outcome Measures

Name	Time	Method
Length of hospital stay in the overall population	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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari; 🇮🇹 Bari, Italy

Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana; 🇮🇹 Vittorio Veneto, Italy

Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy; 🇮🇹 Florence, Italy

Department of Medicine, Surgery and Health Sciences, University of Trieste; 🇮🇹 Trieste, Italy