Actively Recruiting

Age: 18Years +
All Genders
ID06428370

An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD)

Led by Link Campus University · Updated on 2024-06-05

300

Participants Needed

9

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to analyze the potential benefits of damage control surgery, which involves bowel resection, open abdomen, and delayed anastomosis, in treating patients with Hinchey grade III or IV diverticulitis. The study focuses on comparing this approach to other surgical options like the Hartmann procedure and resection with primary anastomosis, particularly in cases of purulent or fecal peritonitis caused by complicated acute large bowel diverticulitis. The treatment being evaluated is Damage Control Surgery, which includes simple resection, dropping the bowel, and leaving the abdomen open temporarily. This approach is considered an alternative to the Hartmann procedure and primary anastomosis, especially in patients with severe sepsis from diverticulitis. The study observes patients who have undergone surgery with this method to describe its rationale and outcomes. Participants in this observational study will be monitored for outcomes such as mortality and morbidity within 60 days after surgery. Researchers will also assess the rate of upfront Hartmann procedures, length of hospital stay, and time spent in the intensive care unit. The study involves follow-up during this 60-day period to understand the effects and potential benefits of Damage Control Surgery in this patient group.

CONDITIONS

Brief Title

Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years who have undergone surgery for Hinchey III or IV diverticulitis
  • Patients treated with resection, clip and drop, and open abdomen techniques
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Acute hospital stay duration

Participants undergo damage control surgery involving resection, clip and drop, and open abdomen techniques for severe acute diverticulitis.

Hospital stay with continuous monitoring

Post-operative Follow-up

Duration - Up to 60 days

Participants are monitored for mortality, morbidity, and recovery outcomes after surgery.

Follow-up visits as per clinical care for up to 60 days

Trial Site Locations

Total: 9 locations

1

Hospital de Urgencia Asistencia Publica

Santiago, Chile

Enrolling by Invitation

2

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy, 00128

Actively Recruiting

3

UOC Chirurgia Generale - Ospedale GB Grassi

Ostia Antica, Roma, Italy, 00122

Actively Recruiting

4

UOC Chirurgia Generale Ospedale Coniugi Bernardini

Palestrina, Roma, Italy, 00036

Actively Recruiting

5

UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano

Caserta, Italy, 81100

Actively Recruiting

6

UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital

Pisa, Italy, 56124

Actively Recruiting

7

Fondazione Policlinico Universitario "A.Gemelli"

Roma, Italy, 00168

Actively Recruiting

8

UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia

Roma, Italy, 00193

Actively Recruiting

9

Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma

Roma, Italy

Actively Recruiting

Loading map...

Research Team

G

Gianluca Costa, Prof.

G

Giuseppina Catanzaro, Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago.

Gennaro Perrone, Mario Giuffrida, Fikri Abu-Zidan...

https://pubmed.ncbi.nlm.nih.gov/38627831

Damage control surgery for perforated diverticulitis with diffuse peritonitis: saves lives and reduces ostomy.

Dario Tartaglia, Gianluca Costa, Antonio Camillò...

https://pubmed.ncbi.nlm.nih.gov/31015859

Comparison between laparoscopic and open Hartmann's reversal: results of a decade-long multicenter retrospective study.

Nir Horesh, Yonatan Lessing, Yaron Rudnicki...

https://pubmed.ncbi.nlm.nih.gov/29766303