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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative treatment (non-operative treatment) | Other | Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity rate for both arms | To compare morbidity (i.e. medical problems related to the treatment) for both conservative and surgical arms | 1 year |
| Mortality rate for both arms | to compare mortality for both conservative and surgical arms |
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Inclusion Criteria:
Patients of both sexes, ≥ 18 years old.
Patients with abdominal CT scan diagnosis of colonic Acute Diverticulitis classifiable as WSES 2B, i.e..
Patients fit for surgery.
Patients with colonic diverticulitis on postoperative histological examination.
Exclusion Criteria:
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Patients affected by WSES 2b acute diverticulitis actively present at participating hospitals
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari | Bari | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | undefined | ||
| 41366193 | Derived | 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. |
| Label | URL |
|---|---|
| Hinchey EJ, Schaal PH, Richards MB. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109. | View source |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Surgical treatment (operative treatment) | Other | Surgical treatment (operative treatment) is explained as follows:
|
|
| 1 year |
| Surgical complications rate | To compare surgical complications rate for the surgical arms (laparoscopy versus open), measured according to Clavien-Dindo Classification (grade 1 to 5) | 1 year |
| Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy | Florence | 50134 | Italy |
|
| Department of Medicine, Surgery and Health Sciences, University of Trieste | Trieste | Italy |
|
| Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana | Vittorio Veneto | Italy |
|
| Neff CC, van Sonnenberg E. CT of diverticulitis. Diagnosis and treatment. Radiol Clin N Am. 1989;27:743-52. | View source |
| 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. | View source |
| 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. | View source |
| 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. | View source |
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| 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. | View source |
| 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. | View source |
| 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 | View source |
| Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446. | View source |
| 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. | View source |
| 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 | View source |
| 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 | View source |
| 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. | View source |
| 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 | View source |