Acute Diverticulitis Clinical Trial
— COLD2BOfficial 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). 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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Azienda Sanitaria di Firenze |
Italy,
undefined
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02785549 -
Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
|
Phase 4 | |
Completed |
NCT03008707 -
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
|
||
Recruiting |
NCT04407793 -
Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis
|
||
Recruiting |
NCT02817854 -
PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study
|
N/A | |
Completed |
NCT03279588 -
Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis
|
||
Recruiting |
NCT06023004 -
The Diverticulitis Study
|
||
Recruiting |
NCT06109506 -
Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis
|
||
Recruiting |
NCT03643718 -
Web-based International Register of Emergency Surgery and Trauma
|
||
Recruiting |
NCT04596280 -
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
|
||
Recruiting |
NCT06265649 -
Comparison of NOM for ACLD Between Medical and Surgical Ward
|
||
Recruiting |
NCT06344078 -
Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).
|
||
Completed |
NCT04663490 -
Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis
|
||
Recruiting |
NCT05162560 -
Incidence and Outcome of Acute Diverticulitis in Finland
|
||
Enrolling by invitation |
NCT05085353 -
Fetal Outcomes Among Pregnant Emergency General Surgery Patients
|
||
Completed |
NCT01840878 -
Validation of Actigraph Measured Sleep During Acute Diverticulitis
|
N/A | |
Not yet recruiting |
NCT01825967 -
Acute Diverticulitis and C-Reactive Protein as a Prognostic Marker
|
N/A | |
Completed |
NCT01840904 -
Subjective Sleep and Fatigue During and After Acute Diverticulitis
|
N/A | |
Completed |
NCT01609751 -
Prevention of Diverticulitis by Taking a Daily Probiotic
|
N/A | |
Completed |
NCT01840852 -
Sleep and Cytokines During Acute Diverticulitis
|
N/A | |
Completed |
NCT01840917 -
Heart Rate Variability During Acute Diverticulitis
|
N/A |