Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388538
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-20
Brief Title:
The COLD2B Multicenter Two-arm Prospective Cohort Study
Sponsor:
Azienda Sanitaria di Firenze
Organization:
Azienda Sanitaria di Firenze
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLD2B
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
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
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 ie traditional open surgery approach with any kind of technique either reconstructive with or without ilealcolonic stoma protection or non-reconstructive see Hartman procedure 2b Laparoscopic approach ie emergency laparoscopic resection with the characteristics mentioned above The enrollment period and the overall evaluation will last approximately 1 year
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 ie traditional open surgery approach with any kind of technique either reconstructive with or without ilealcolonic stoma protection or non-reconstructive see Hartman procedure 2b Laparoscopic approach ie emergency laparoscopic resection with the characteristics mentioned above The enrollment period and the overall evaluation will last approximately 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None