An observational study in Diverticulitis, sponsored by University of Roma La Sapienza. Completed at 9 sites in Italy. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University of Roma La Sapienza · Observational
To evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of Hinchey III or IV diverticulitis.
Despite the progress in the resuscitation modalities of septic patients, Hartmann procedure (HP) is still considered the safest treatment for generalized peritonitis as a consequence of a complicated acute diverticulitis (stages III and IV of the Hinchey's classification). Almost the half of those patients do not have their stoma reversed because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) is a matter of debate, as it is reported in the literature that it is substantially equivalent to HP in terms of morbidity and length of postoperative stay. For these reason, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination. In the last decade, Damage Control Surgery has been emerging as a valid alternative to HP and RA in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Initially described for the treatment of major abdominal injuries, indications for DCS have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. However, there is still no consensus about the use of DCS in perforated acute diverticulitis.
The aim of this study was to describe "how-to-use" the Damage Control Surgery in patients with purulent and fecal peritonitis following a severe acute diverticulitis and report the impact on patients' outcomes after the application of this technique in several Italian centers of emergency surgery
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 121 is below the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients operated on for Hinchey III or IV class and treated by damage control surgery procedure
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Exclusion Criteria:
Mortality
Mortality rate related to treatment
Time frame: 6 months
Morbidity
Complications rate arranged by Clavien-Dindo classification I to IV
Time frame: 6 months
Lenght of stay (LOS)
Days of stay as inpatient
Time frame: 6 months
ICU lenght of stay
Days of stay as
Time frame: 12 months
Number of Hartmann's procedure
Observed to expected (O:E) ratio of Hartmann's procedures
Time frame: 1 month
Plan to share: Yes — Individual participant data (IPD) will probably be shared with other researchers
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Since six months from study start to six months from study completion
Access criteria: By request
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza →