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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Open Abdomen; Diverticular Perforation
• Intervention / Treatment: Procedure: Damage Control Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gianluca Costa, Prof.; Phone Number: +39 06 22541 8851; Email: g.costa@unilink.it
• Study Contact Backup: Name: Giuseppina Catanzaro, Prof.; Email: g.catanzaro@unilink.it

Study Locations

• Chile
  • Santiago de Chile, Chile
    • Enrolling by invitation
    • Hospital de Urgencia Asistencia Publica
• Italy
  • Caserta, Italy, 81100
    • Recruiting
    • UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano
    • Contact: Mauro Andreano, Prof.
    • Principal Investigator: Alberto Mingione, MD
  • Pisa, Italy, 56124
    • Recruiting
    • UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital
    • Principal Investigator: Dario Tartaglia, MD
    • Contact: Massimo Chiarugi, MD, FACS
  • Roma, Italy, 00193
    • Recruiting
    • UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia
    • Contact: Luca Lepre, MD, PhD
    • Principal Investigator: Michela Giulii Capponi, MD
  • Roma, Italy
    • Recruiting
    • Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma
    • Contact: Andrea Mingoli, Prof.
    • Principal Investigator: Gioia Brachini, MD, PhD
    • Sub-Investigator: Bruno Cirillo, MD, PhD
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario "A.Gemelli"
    • Principal Investigator: Pietro Fransvea, MD
    • Contact: Gabriele Sganga, MD, FACS
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Recruiting
      • Fondazione Policlinico Universitario Campus Bio-Medico
      • Contact: Marco Caricato, MD, PhD
      • Principal Investigator: Gabriella T Capolupo, MD, PhD
  • Roma
    • Ostia, Roma, Italy, 00122
      • Recruiting
      • UOC Chirurgia Generale - Ospedale GB Grassi
      • Contact: Gianluca Mazzoni, MD, PhD
      • Contact: Anna Maria Bellotti, MD; Email: annamaria.bellotti@aslroma3.it
      • Principal Investigator: Loretta Di Cristofaro, MD
    • Palestrina, Roma, Italy, 00036
      • Recruiting
      • UOC Chirurgia Generale Ospedale Coniugi Bernardini
      • Contact: Gianluca Liotta, MD, PhD; Phone Number: +39 06 95321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Same as above

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate related to treatment	60 days
Morbidity	Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system	60 days
Total morbidity	Morbidity calculated by means of the Comprehensive Complication Index	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upfront Hartmann rate	Observed to expected (O:E) ratio of Hartmann's procedures	60 days
Length of stay (LOS)	Days of stay as inpatient	60 days
ICU length of stay	Days of stay in ICU	60 days

Collaborators and Investigators

• Sponsor: Link Campus University
• Investigators: Study Director: Gianluca Costa, Prof., Link Campus University

Publications and helpful links

General Publications

• Costa G, La Torre M, Frezza B, Fransvea P, Tomassini F, Ziparo V, Balducci G. Changes in the surgical approach to colonic emergencies during a 15-year period. Dig Surg. 2014;31(3):197-203. doi: 10.1159/000365254. Epub 2014 Aug 28.
• Khan A, Hsee L, Mathur S, Civil I. Damage-control laparotomy in nontrauma patients: review of indications and outcomes. J Trauma Acute Care Surg. 2013 Sep;75(3):365-8. doi: 10.1097/TA.0b013e31829cb65e.
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Kwiatkowski A, Czyzykowski L, da Costa SD, Pereira B, Ferreira ARO, Almeida F, Rocha R, Carneiro C, Perez DP, Carvas J, Rocha C, Ferreira C, Marques R, Fernandes U, Leao P, Goulart A, Pereira RG, Patrocinio SDD, de Mendonca NGG, Manso MIC, Morais HMC, Cardoso PS, Calu V, Miron A, Toma EA, Gachabayov M, Abdullaev A, Litvin A, Nechay T, Tyagunov A, Yuldashev A, Bradley A, Wilson M, Panyko A, Lateckova Z, Lacko V, Lesko D, Soltes M, Radonak J, Turrado-Rodriguez V, Termes-Serra R, Morales-Sevillano X, Lapolla P, Mingoli A, Brachini G, Degiuli M, Sofia S, Reddavid R, de Manzoni Garberini A, Buffone A, Del Pozo EP, Aparicio-Sanchez D, Dos Barbeito S, Estaire-Gomez M, Viton-Herrero R, de Los Angeles Gil Olarte-Marquez M, Gil-Martinez J, Alconchel F, Nicolas-Lopez T, Rahy-Martin AC, Pelloni M, Banolas-Suarez R, Mendoza-Moreno F, Nisa FG, Diez-Alonso M, Rodas MEV, Agundez MC, Andres MIP, Moreira CCL, Perez AL, Ponce IA, Gonzalez-Castillo AM, Membrilla-Fernandez E, Salvans S, Serradilla-Martin M, Pardo PS, Rivera-Alonso D, Dziakova J, Huguet JM, Valle NP, Ruiz EC, Valcarcel CR, Moreno CR, Salazar YTM, Garcia JJR, Mico SS, Lopez JR, Farre SP, Gomez MS, Petit NM, Titos-Garcia A, Aranda-Narvaez JM, Romacho-Lopez L, Sanchez-Guillen L, Aranaz-Ostariz V, Bosch-Ramirez M, Martinez-Perez A, Martinez-Lopez E, Sebastian-Tomas JC, Jimenez-Riera G, Jimenez-Vega J, Cuellar JAN, Campos-Serra A, Munoz-Campana A, Gracia-Roman R, Alegre JM, Pinto FL, O'Sullivan SN, Antona FB, Jimenez BM, Lopez-Sanchez J, Carmona ZG, Fernandez RT, Sierra IB, de Leon LRG, Moreno VP, Iglesias E, Cumplido PL, Bravo AA, Simo IR, Dominguez CL, Caamano AG, Lozano RC, Martinez MD, Torres AN, de Quiros JTMB, Pellino G, Cloquell MM, Moller EG, Jalal-Eldin S, Abdoun AK, Hamid HKS, Lohsiriwat V, Mongkhonsupphawan A, Baraket O, Ayed K, Abbassi I, Ali AB, Ammar H, Kchaou A, Tlili A, Zribi I, Colak E, Polat S, Koylu ZA, Guner A, Usta MA, Reis ME, Mantoglu B, Gonullu E, Akin E, Altintoprak F, Bayhan Z, Firat N, Isik A, Memis U, Bayrak M, Altintas Y, Kara Y, Bozkurt MA, Kocatas A, Das K, Seker A, Ozer N, Atici SD, Tuncer K, Kaya T, Ozkan Z, Ilhan O, Agackiran I, Uzunoglu MY, Demirbas E, Altinel Y, Meric S, Hacim NA, Uymaz DS, Omarov N, Balik E, Tebala GD, Khalil H, Rana M, Khan M, Florence C, Swaminathan C, Leo CA, Liasis L, Watfah J, Trostchansky I, Delgado E, Pontillo M, Latifi R, Coimbra R, Edwards S, Lopez A, Velmahos G, Dorken A, Gebran A, Palmer A, Oury J, Bardes JM, Seng SS, Coffua LS, Ratnasekera A, Egodage T, Echeverria-Rosario K, Armento I, Napolitano LM, Sangji NF, Hemmila M, Quick JA, Austin TR, Hyman TS, Curtiss W, McClure A, Cairl N, Biffl WL, Truong HP, Schaffer K, Reames S, Banchini F, Capelli P, Coccolini F, Sartelli M, Bravi F, Vallicelli C, Agnoletti V, Baiocchi GL, Catena F. Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago. World J Emerg Surg. 2024 Apr 16;19(1):14. doi: 10.1186/s13017-024-00543-w.
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Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Septic shock; Diverticulitis; Open abdomen
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: LCU MEDS-06/A 01/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No