## Protocol Section
### Identification Module
**NCT ID:** NCT06428370

**Acronym:** DACOSAD

**Brief Title:** Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)

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

#### Organization Study ID Info
**ID:** LCU MEDS-06/A 01/2024
#### Organization
**Class:** OTHER
**Full Name:** Link Campus University
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Link Campus University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Diverticular Perforation

- Open Abdomen

**Keywords:**

- Diverticulitis

- Surgery

- Open abdomen

- Septic shock

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Damage Control Surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Mortality rate related to treatment

**Measure:** Mortality

**Time Frame:** 60 days

**Description:** Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system

**Measure:** Morbidity

**Time Frame:** 60 days

**Description:** Morbidity calculated by means of the Comprehensive Complication Index

**Measure:** Total morbidity

**Time Frame:** 60 days

#### Secondary Outcomes

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

**Measure:** Upfront Hartmann rate

**Time Frame:** 60 days

**Description:** Days of stay as inpatient

**Measure:** Length of stay (LOS)

**Time Frame:** 60 days

**Description:** Days of stay in ICU

**Measure:** ICU length of stay

**Time Frame:** 60 days

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Same as above

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** g.costa@unilink.it

**Name:** Gianluca Costa, Prof.

**Phone:** +39 06 22541 8851

**Role:** CONTACT

**Contact 2:**

**Email:** g.catanzaro@unilink.it

**Name:** Giuseppina Catanzaro, Prof.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Name:** Marco Caricato, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gabriella T Capolupo, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Fondazione Policlinico Universitario Campus Bio-Medico

**State:** Lazio

**Status:** RECRUITING

**Zip:** 00128

**Location 2:**

**City:** Ostia

**Contacts:**

***Contact 1:***

- **Name:** Gianluca Mazzoni, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** annamaria.bellotti@aslroma3.it

- **Name:** Anna Maria Bellotti, MD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Loretta Di Cristofaro, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** UOC Chirurgia Generale - Ospedale GB Grassi

**State:** Roma

**Status:** RECRUITING

**Zip:** 00122

**Location 3:**

**City:** Palestrina

**Contacts:**

***Contact 1:***

- **Name:** Gianluca Liotta, MD, PhD

- **Phone:** +39 06 95321

- **Role:** CONTACT

**Country:** Italy

**Facility:** UOC Chirurgia Generale Ospedale Coniugi Bernardini

**State:** Roma

**Status:** RECRUITING

**Zip:** 00036

**Location 4:**

**City:** Caserta

**Contacts:**

***Contact 1:***

- **Name:** Mauro Andreano, Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alberto Mingione, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano

**Status:** RECRUITING

**Zip:** 81100

**Location 5:**

**City:** Pisa

**Contacts:**

***Contact 1:***

- **Name:** Massimo Chiarugi, MD, FACS

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dario Tartaglia, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital

**Status:** RECRUITING

**Zip:** 56124

**Location 6:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Name:** Gabriele Sganga, MD, FACS

- **Role:** CONTACT

***Contact 2:***

- **Name:** Pietro Fransvea, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Fondazione Policlinico Universitario "A.Gemelli"

**Status:** RECRUITING

**Zip:** 00168

**Location 7:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Name:** Luca Lepre, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Michela Giulii Capponi, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia

**Status:** RECRUITING

**Zip:** 00193

**Location 8:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Name:** Andrea Mingoli, Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gioia Brachini, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Bruno Cirillo, MD, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Italy

**Facility:** Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Link Campus University

**Name:** Gianluca Costa, Prof.

**Role:** STUDY_DIRECTOR

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000076385

- Term: Diverticular Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC01

- Name: Infections

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M7414

- Name: Diverticulitis

- Relevance: HIGH

- As Found: Diverticulitis

- ID: M15580

- Name: Shock, Septic

- Relevance: LOW

- As Found: Unknown

- ID: M7416

- Name: Diverticulum

- Relevance: LOW

- As Found: Unknown

- ID: M1603

- Name: Diverticular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004238

- Term: Diverticulitis

### Misc Info Module

- Version Holder: 2024-05-31
