An observational study in Diverticular Perforation and Open Abdomen, sponsored by Link Campus University. Recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Link Campus University · Observational
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.
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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's planned enrollment of 300 is close to the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →Link Campus University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Simple resection, drop, and open abdomen in case of Hinchey III-IV
Mortality
Mortality rate related to treatment
Time frame: 60 days
Morbidity
Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system
Time frame: 60 days
Total morbidity
Morbidity calculated by means of the Comprehensive Complication Index
Time frame: 60 days
Upfront Hartmann rate
Observed to expected (O:E) ratio of Hartmann's procedures
Time frame: 60 days
Length of stay (LOS)
Days of stay as inpatient
Time frame: 60 days
ICU length of stay
Days of stay in ICU
Time frame: 60 days
Started Jan 2020 (actual). Primary completion is estimated for Dec 2024, 59 months after the start.
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