Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428370
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-20
Brief Title:
Damage Control Surgery Over the World in Acute Diverticulitis DACOSAD
Sponsor:
Link Campus University
Organization:
Link Campus University
Study Overview
Official Title:
An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis DACOSAD
Status:
RECRUITING
Status Verified Date:
2024-06
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:
DACOSAD
Brief Summary:
To analyze the possible benefit of damage control surgery by performing bowel resection open abdomen and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis
Detailed Description:
Hartmann procedure HP is still widely performed in the treatment of purulent or fecal generalized peritonitis as a consequence of a complicated acute large bowel diverticulitis the so labeled III and IV grade of the Hincheys classification More than half of those patients do not undergo to stoma reversal because of its association with significant morbidity and mortality To date the use of resection with primary anastomosis PA should be preferred as it is reported in the literature that it is more favorable than HP in terms of morbidity mortality and length of postoperative stay However PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination while HP is performed in the elderly Initially described for the treatment of major abdominal injuries indications for Damage Control Surgery DCS have subsequently been extended to septic shock abdominal compartment syndrome and impossibility to perform a primary closure In the last decade DCS has emerged as a valid alternative to HP and Resection-Anastomosis RA in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis Although DCS is cited as an option in case of impaired hemodynamic status in face of perforated acute diverticulitis there is still no consensus about such use of DCS Previous study demonstrated that DCS reduce the Hartmann rate in patients otherwise scheduled for such procedure
The aim of this study was to describe the potential rationale and outcome of the Damage Control Surgery in patients with purulent and fecal peritonitis
The aim of this study was to describe the potential rationale and outcome of the Damage Control Surgery in patients with purulent and fecal peritonitis
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