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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06428370
Acronym
DACOSAD
Enrollment
300
Registered
2024-05-24
Start date
2020-01-01
Completion date
2025-06-01
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticular Perforation, Open Abdomen

Keywords

Diverticulitis, Surgery, Open abdomen, Septic shock

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 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.

Interventions

Simple resection, drop, and open abdomen in case of Hinchey III-IV

Sponsors

Link Campus University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients \>18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen

Exclusion criteria

* Subjects \<18 year-old

Design outcomes

Primary

MeasureTime frameDescription
Mortality60 daysMortality rate related to treatment
Morbidity60 daysMorbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system
Total morbidity60 daysMorbidity calculated by means of the Comprehensive Complication Index

Secondary

MeasureTime frameDescription
Upfront Hartmann rate60 daysObserved to expected (O:E) ratio of Hartmann's procedures
Length of stay (LOS)60 daysDays of stay as inpatient
ICU length of stay60 daysDays of stay in ICU

Countries

Chile, Italy

Contacts

Primary ContactGianluca Costa, Prof.
g.costa@unilink.it+39 06 22541 8851
Backup ContactGiuseppina Catanzaro, Prof.
g.catanzaro@unilink.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026