Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06428370

Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)

An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD)

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Link Campus University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 Hinchey's 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDamage Control SurgerySimple resection, drop, and open abdomen in case of Hinchey III-IV

Timeline

Start date
2020-01-01
Primary completion
2024-12-31
Completion
2025-06-01
First posted
2024-05-24
Last updated
2024-06-05

Locations

9 sites across 2 countries: Chile, Italy

Source: ClinicalTrials.gov record NCT06428370. Inclusion in this directory is not an endorsement.