The COLD2B Multicenter, Two-arm Prospective Cohort Study

NCT06388538 | Not Yet Recruiting

• 1 other identifier: Carlo Bergamini
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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).

Conditions

Acute Diverticulitis

Keywords

COLD2b; acute diverticulitis stage 2B WSES; sigmoid acute diverticulitis; left-side colonic acute diverticulitis

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay in the overall population

  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 Outcomes (3)

• Morbidity rate for both arms

  1 year

• Mortality rate for both arms

  1 year

• Surgical complications rate

  1 year

Study Arms (1)

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); Other: Surgical treatment (operative treatment)

Interventions

Conservative treatment (non-operative treatment) OTHER

Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage)

Patients with WSES stage 2b acute diverticulitis

Surgical treatment (operative treatment) OTHER

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

Patients with WSES stage 2b acute diverticulitis

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

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

You may qualify if:

• Patients of both sexes, ≥ 18 years old.
• Patients with abdominal CT scan diagnosis of colonic Acute Diverticulitis classifiable as WSES 2B, i.e..
• thickening and other phlegmon signs of the left-sided colonic wall (mostly sigmoid) associated with the inflammatory involvement of the surrounding tissues, plus
• presence of air bubbles distant more than 5 cm from the primary colonic inflammatory localization, plus
• absence of conspicuous free fluid collection or pelvic abscess.
• Patients fit for surgery.
• Patients with colonic diverticulitis on postoperative histological examination.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria di Firenze: lead

Study Sites (4)

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

Bari, Italy

Location

Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy

Florence, 50134, Italy

Location

Department of Medicine, Surgery and Health Sciences, University of Trieste

Trieste, Italy

Location

Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana

Vittorio Veneto, Italy

Location

Related Publications (2)

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  BACKGROUND

• Giordano A, Mastronardi M, Montori G, Anania G, Bergamini C. A focus of therapeutic strategies in acute diverticulitis with distant free air: a systematic review. Updates Surg. 2025 Dec 9. doi: 10.1007/s13304-025-02467-9. Online ahead of print.

  PMID: 41366193 DERIVED

Related Links

• Hinchey EJ, Schaal PH, Richards MB. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.
• Neff CC, van Sonnenberg E. CT of diverticulitis. Diagnosis and treatment. Radiol Clin N Am. 1989;27:743-52.
• Ambrosetti P, Becker C, Terrier F. Colonic diverticulitis: impact of imaging on surgical management-a prospective study of 542 patients. Eur Radiol. 2002;12:1145-9.
• Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, et al. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol. 2005;100:910-7.
• Mora Lopez L, Serra Pla S, Serra-Aracil X, Ballesteros E, Navarro S. Application of a modified Neff classification to patients with uncomplicated diverticulitis. Color Dis. 2013;15:1442-7.
• Sallinen VJ, Leppäniemi AK, Mentula PJ. Staging of acute diverticulitis based on clinical, radiologic, and physiologic parameters. J Trauma Acute Care Surg. 2015;78:543-51.
• Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, et al. WSES guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016;11:37.
• Sartelli M, Weber DG, Kluger Y, Ansaloni L, Coccolini F, et al. 2020 update of the WSES guidelines for the management of acute colonic diverticulitis in the emergency setting. World J Emerg Surg. 2020 May 7;15(1):32.
• Francis NK, Sylla P, Abou-Khalil M, et al. EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice. Surg Endosc. 2019; 33:2726-2741
• Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446.
• Karentzos A, Ntourakis D, Tsilidis K, Tsoulfas G, Papavramidis T. Hinchey Ia acute diverticulitis with isolated pericolic air on CT imaging; to operate or not? A systematic review.
• Dharmarajan S, Hunt SR, Birnbaum EH, Fleshman JW, Mutch MG. The efficacy of nonoperative management of acute complicated diverticulitis. Dis Colon Rectum. 2011;54:663-71. Int J Surg. 2021;85:1-9
• Sallinen VJ, Mentula PJ, Leppäniemi AK. Nonoperative management of perforated diverticulitis with extraluminal air is safe and effective in selected patients.. Dis Colon Rectum. 2014;57:875-881
• Toro A, Mannino M, Reale G, Cappello G, Di Carlo. Primary anastomosis vs Hartmann procedure in acute complicated diverticulitis. Evolution over the last twenty years. Chirurgia (Bucur) 2012;107:598-604.
• Agnes et al Management of acute diverticulitis in Stage 0-IIb: indications and risk factors for failure of conservative treatment in a series of 187 patients. Sci Rep. 2024 Jan 17;14(1):1501

MeSH Terms

Interventions

Conservative Treatment; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Carlo Bergamini Carlo Bergamini, M.D.

CONTACT

0039(0)557949173; drcarlobergamini@gmail.com

Alessio Biagio Giordano Alessio Giordano, MD

CONTACT

+390557949173; alessio.giordano8@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 29, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

IT (4)