Clinical trial NCT03337984: Damage Control Surgery in the Treatment of Complicated Diverticulitis
Official title: Damage Control Surgery in the Treatment of Hinchey Stage III and IV Diverticulitis: an Italian Nationwide Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulitis
Keywords: Diverticulitis
Damage Control Surgery
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on for Hinchey III or IV class and treated by damage control surgery procedure

Brief summary: To evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of Hinchey III or IV diverticulitis.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for Hinchey III and IV stage scheduled for immediate Hartmann's procedure and ICU recovery

Exclusion Criteria:

* None

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity
timeFrame: 6 months
measure: Lenght of stay (LOS)
timeFrame: 6 months
measure: ICU lenght of stay
timeFrame: 12 months
measure: Number of Hartmann's procedure
timeFrame: 1 month
Other outcomes:
Locations:
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
state: Bergamo
city: Napoli
country: Italy
facility: Azienda Ospedaliera Cardarelli
state: Campania
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
state: Marche
city: Adria
country: Italy
facility: Ospedale Civile di Adria
state: Rovigo
city: Arezzo
country: Italy
facility: Ospedale San Donato
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
state: Toscana
city: Foligno
country: Italy
facility: Ospedale San Giovanni Battista
state: Umbria
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
state: Umbria
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
state: Veneto
Study officials:
affiliation: University of Roma La Sapienza, Sant' Andrea University Hospital
name: Gianluca Costa, MD, PhD
role: STUDY_DIRECTOR
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