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

NCT ID: NCT06428370

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-06-01

Brief Summary

To analyze the possible benefit of damage control surgery by performing bowel resection, open abdomen, and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis.

Detailed Description

Hartmann procedure (HP) is still widely performed in the treatment of purulent or fecal generalized peritonitis as a consequence of a complicated acute large bowel diverticulitis (the so labeled III and IV grade of the Hinchey's classification). More than half of those patients do not undergo to stoma reversal because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) should be preferred, as it is reported in the literature that it is more favorable than HP in terms of morbidity, mortality, and length of postoperative stay. However, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination while HP is performed in the elderly. Initially described for the treatment of major abdominal injuries, indications for Damage Control Surgery (DCS) have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. In the last decade, DCS has emerged as a valid alternative to HP and Resection-Anastomosis (RA) in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Although DCS is cited as an option in case of impaired hemodynamic status in face of perforated acute diverticulitis, there is still no consensus about such use of DCS. Previous study demonstrated that DCS reduce the Hartmann rate in patients otherwise scheduled for such procedure.

The aim of this study was to describe the potential rationale and outcome of the Damage Control Surgery in patients with purulent and fecal peritonitis.

Conditions

Diverticular Perforation; Open Abdomen

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Damage Control Surgery

Simple resection, drop, and open abdomen in case of Hinchey III-IV

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients >18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen

Exclusion Criteria

• Subjects <18 year-old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Link Campus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianluca Costa, Prof.

Role: STUDY_DIRECTOR

Link Campus University

Locations

Hospital de Urgencia Asistencia Publica

Santiago, , Chile

Site Status: ENROLLING_BY_INVITATION

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy

Site Status: RECRUITING

UOC Chirurgia Generale - Ospedale GB Grassi

Ostia Antica, Roma, Italy

Site Status: RECRUITING

UOC Chirurgia Generale Ospedale Coniugi Bernardini

Palestrina, Roma, Italy

Site Status: RECRUITING

UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano

Caserta, , Italy

Site Status: RECRUITING

UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital

Pisa, , Italy

Site Status: RECRUITING

Fondazione Policlinico Universitario "A.Gemelli"

Roma, , Italy

Site Status: RECRUITING

UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia

Roma, , Italy

Site Status: RECRUITING

Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma

Roma, , Italy

Site Status: RECRUITING

Countries

Chile; Italy

Central Contacts

Gianluca Costa, Prof.

Role: CONTACT

g.costa@unilink.it

+39 06 22541 8851

Giuseppina Catanzaro, Prof.

Role: CONTACT

g.catanzaro@unilink.it

Facility Contacts

Marco Caricato, MD, PhD

Role: primary

Gianluca Mazzoni, MD, PhD

Role: primary

Anna Maria Bellotti, MD

Role: backup

annamaria.bellotti@aslroma3.it

Gianluca Liotta, MD, PhD

Role: primary

+39 06 95321

Mauro Andreano, Prof.

Role: primary

Massimo Chiarugi, MD, FACS

Role: primary

Gabriele Sganga, MD, FACS

Role: primary

Luca Lepre, MD, PhD

Role: primary

Andrea Mingoli, Prof.

Role: primary

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Other Identifiers

LCU MEDS-06/A 01/2024

Identifier Type: -

Identifier Source: org_study_id