The COLD2B Multicenter, Two-arm Prospective Cohort Study

Acute Diverticulitis Clinical Trial

— COLD2B  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388538
• Other study ID #: Carlo Bergamini
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Azienda Sanitaria di Firenze
• Contact: Carlo Bergamini Carlo Bergamini, M.D.
• Phone: 0039(0)557949173
• Email: drcarlobergamini[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Intervention

Other:
• Conservative treatment (non-operative treatment)
Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage)
• Surgical treatment (operative treatment)
Surgical treatment (operative treatment) is explained as follows: 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) Laparoscopic approach, i.e. emergency laparoscopic resection with the characteristics mentioned above

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari	Bari
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	Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana	Vittorio Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria di Firenze

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity rate for both arms	To compare morbidity (i.e. medical problems related to the treatment) for both conservative and surgical arms	1 year
Secondary	Mortality rate for both arms	to compare mortality for both conservative and surgical arms	1 year
Secondary	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

External Links

•   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
•   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.
•   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
•   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
•   Hinchey EJ, Schaal PH, Richards MB. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.
•   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.
•   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.
•   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.
•   Neff CC, van Sonnenberg E. CT of diverticulitis. Diagnosis and treatment. Radiol Clin N Am. 1989;27:743-52.
•   Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446.
•   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.
•   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
•   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.
•   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.