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Completed

NCT Number: NCT03337984

Damage Control Surgery in the Treatment of Complicated Diverticulitis

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico San Pietro, Ponte San Pietro, Bergamo, Italy

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 6 months

    Mortality rate related to treatment

Secondary outcomes

  1. Morbidity

    Time frame: 6 months

    Complications rate arranged by Clavien-Dindo classification I to IV

  2. Lenght of stay (LOS)

    Time frame: 6 months

    Days of stay as inpatient

  3. ICU lenght of stay

    Time frame: 12 months

    Days of stay as

  4. Number of Hartmann's procedure

    Time frame: 1 month

    Observed to expected (O:E) ratio of Hartmann's procedures

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Damage Control Surgery in the Treatment of Hinchey Stage III and IV Diverticulitis: an Italian Nationwide Survey

Acronym: DACSCOD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2017
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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