Acute DiverticulitisCOLD2BNCT06388538
The COLD2B Multicenter, Two-arm Prospective Cohort Study
An observational study of Acute Diverticulitis, run by Azienda Sanitaria di Firenze at 4 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Conservative treatment (non-operative treatment) and Surgical treatment (operative treatment)
- How many people
- 500 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by WSES 2b acute diverticulitis actively present at participating hospitals
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari
Bari
Francesco Paolo Prete
Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy
Florence, 50134
Carlo Bergamini, MD, +39(0)557949173, drcarlobergamini@gmail.com
Carlo Bergamini
Department of Medicine, Surgery and Health Sciences, University of Trieste
Trieste
Manuela Mastronardi
Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana
Vittorio Veneto
Giulia Montori
About this study
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
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).
Read more
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).
Read the 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:
- Conservatively treated, which will include patients treated with medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage) and
- 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.
- Conditions
- Acute Diverticulitis
- Being tested
- Conservative treatment (non-operative treatment), Surgical treatment (operative treatment)
- Keywords
- COLD2b, acute diverticulitis stage 2B WSES, sigmoid acute diverticulitis, left-side colonic acute diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment (non-operative treatment)Other
Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage)
Surgical treatment (operative treatment)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Conservative treatment (non-operative treatment); Other: Surgical treatment (operative treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Morbidity rate for both arms
To compare morbidity (i.e. medical problems related to the treatment) for both conservative and surgical arms
Measured: 1 year
Mortality rate for both arms
to compare mortality for both conservative and surgical arms
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria di Firenze
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giordano, Azienda Sanitaria di Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388538
- Sponsor's protocol ID
- Carlo Bergamini
- Acronym
- COLD2B
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
undefined
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.
PubMed 41366193
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06388538
- Acronym / sponsor ID
- COLD2B / Carlo Bergamini
- Conditions
- Acute Diverticulitis
- Keywords
- COLD2b, acute diverticulitis stage 2B WSES, sigmoid acute diverticulitis, left-side colonic acute diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Sanitaria di FirenzeUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Conservatively treated, which will include patients treated with medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage) and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with WSES stage 2b acute diverticulitis | – | Other: Conservative treatment (non-operative treatment), Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by WSES 2b acute diverticulitis actively present at participating hospitals
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Right-sided or transverse diverticulitis
- Concomitant bowel abscess, perforation, or fistula
- Radiological drainage
- Elective procedures.
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatment (non-operative treatment)Conservative treatment consists of medical therapy (see fluid, anti-pain drugs and antibiotics, except for radiologic drainage) | Other | Patients with WSES stage 2b acute diverticulitis |
| 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 | Other | Patients with WSES stage 2b acute diverticulitis |
Primary outcome
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
3 secondary outcomes
Morbidity rate for both arms
Time frame: 1 year
Mortality rate for both arms
Time frame: 1 year
Surgical complications rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Backgroundundefined
- Derived from this study: PubMed 41366193Giordano 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.
- Hinchey EJ, Schaal PH, Richards MB. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.Link provided by the sponsor.
- Neff CC, van Sonnenberg E. CT of diverticulitis. Diagnosis and treatment. Radiol Clin N Am. 1989;27:743-52.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis, run by Azienda Sanitaria di Firenze at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Bergamini Carlo Bergamini, M.D. (0039(0)557949173, drcarlobergamini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay in the overall population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.