Damage Control Surgery in the Treatment of Complicated Diverticulitis (DACSCOD)

May 16, 2021 updated by: Gianluca Costa, University of Roma La Sapienza

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bergamo
      • Ponte San Pietro, Bergamo, Italy
        • Policlinico San Pietro
    • Campania
      • Napoli, Campania, Italy
        • Azienda Ospedaliera Cardarelli
    • Marche
      • Ancona, Marche, Italy, 60121
        • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
    • Rovigo
      • Adria, Rovigo, Italy
        • Ospedale Civile di Adria
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • Ospedale San Donato
      • Pisa, Toscana, Italy, 56121
        • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
    • Umbria
      • Foligno, Umbria, Italy, 06034
        • Ospedale San Giovanni Battista
      • Terni, Umbria, Italy
        • Azienda Ospedaliera Santa Maria
    • Veneto
      • Abano Terme, Veneto, Italy, 35031
        • Policlinico Abano Terme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated on for Hinchey III or IV class and treated by damage control surgery procedure

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6 months
Mortality rate related to treatment
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Gianluca Costa, MD, PhD, University of Roma La Sapienza, Sant' Andrea University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-SURG AOSA 2017_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will probably be shared with other researchers

IPD Sharing Time Frame

Since six months from study start to six months from study completion

IPD Sharing Access Criteria

By request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diverticulitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe