Damage Control Surgery in the Treatment of Complicated Diverticulitis

Completed

• Conditions: Diverticulitis

• Registration Number: NCT03337984
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Study First Submitted: 2017-06-12
• Study Start: 2017-09-01
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	6 months	Mortality rate related to treatment

Secondary Outcome Measures

Name	Time	Method
Lenght of stay (LOS)	6 months	Days of stay as inpatient
ICU lenght of stay	12 months	Days of stay as
Morbidity	6 months	Complications rate arranged by Clavien-Dindo classification I to IV
Number of Hartmann's procedure	1 month	Observed to expected (O:E) ratio of Hartmann's procedures

Trial Locations

Locations (9)

Policlinico Abano Terme; 🇮🇹 Abano Terme, Veneto, Italy

Azienda Ospedaliera Cardarelli; 🇮🇹 Napoli, Campania, Italy

Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona; 🇮🇹 Ancona, Marche, Italy

Azienda Ospedaliera Pisana Policlinico Universitario Cisanello; 🇮🇹 Pisa, Toscana, Italy

Ospedale San Donato; 🇮🇹 Arezzo, Toscana, Italy

Ospedale San Giovanni Battista; 🇮🇹 Foligno, Umbria, Italy

Policlinico San Pietro; 🇮🇹 Ponte San Pietro, Bergamo, Italy

Azienda Ospedaliera Santa Maria; 🇮🇹 Terni, Umbria, Italy

Ospedale Civile di Adria; 🇮🇹 Adria, Rovigo, Italy