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

Open Abdomen Clinical Trial

— DACOSAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428370
• Other study ID #: LCU MEDS-06/A 01/2024
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Link Campus University
• Contact: Gianluca Costa, Prof.
• Phone: +39 06 22541 8851
• Email: g.costa[@]unilink.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Open Abdomen

Intervention

Procedure:
• Damage Control Surgery
Simple resection, drop, and open abdomen in case of Hinchey III-IV

Locations

Country	Name	City	State
Chile	Hospital de Urgencia Asistencia Publica	Santiago de Chile
Italy	UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano	Caserta
Italy	UOC Chirurgia Generale - Ospedale GB Grassi	Ostia	Roma
Italy	UOC Chirurgia Generale Ospedale Coniugi Bernardini	Palestrina	Roma
Italy	UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital	Pisa
Italy	Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma	Roma
Italy	Fondazione Policlinico Universitario "A.Gemelli"	Roma
Italy	Fondazione Policlinico Universitario Campus Bio-Medico	Roma	Lazio
Italy	UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Link Campus University

Countries where clinical trial is conducted

Chile,  Italy, 

References & Publications (11)

Berg A, Rosenzweig M, Kuo YH, Onayemi A, Mohidul S, Moen M, Sciarretta J, Davis JM, Ahmed N. The results of rapid source control laparotomy or open abdomen for acute diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):259-265. doi: 10.1007/s00423-021-0 — View Citation

Cirocchi R, Sapienza P, Anania G, Binda GA, Avenia S, di Saverio S, Tebala GD, Zago M, Donini A, Mingoli A, Nascimbeni R. State-of-the-art surgery for sigmoid diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):1-14. doi: 10.1007/s00423-021-02288-5. Epub 2021 Sep 23. — View Citation

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. — View Citation

Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner J, Gutman M, Zmora O, Tulchinsky H. Comparison between laparoscopic and open Hartmann's reversal: results of a decade-long mul — View Citation

Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Tulchinsky H, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner JM, Gutman M, Zmora O. Considerations for Hartmann's reversal and Hartmann's reversal outcomes-a multicenter stu — View Citation

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. — View Citation

Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446. doi: 10.7759/cureus.28446. eCollection 2022 Aug. — View Citation

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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. — View Citation

Sohn M, Agha A, Iesalnieks I, Gundling F, Presl J, Hochrein A, Tartaglia D, Brillantino A, Perathoner A, Pratschke J, Aigner F, Ritschl P. Damage control strategy in perforated diverticulitis with generalized peritonitis. BMC Surg. 2021 Mar 16;21(1):135. doi: 10.1186/s12893-021-01130-5. — View Citation

Tartaglia D, Costa G, Camillo A, Castriconi M, Andreano M, Lanza M, Fransvea P, Ruscelli P, Rimini M, Galatioto C, Chiarugi M. Damage control surgery for perforated diverticulitis with diffuse peritonitis: saves lives and reduces ostomy. World J Emerg Sur — View Citation

Zizzo M, Castro Ruiz C, Zanelli M, Bassi MC, Sanguedolce F, Ascani S, Annessi V. Damage control surgery for the treatment of perforated acute colonic diverticulitis: A systematic review. Medicine (Baltimore). 2020 Nov 25;99(48):e23323. doi: 10.1097/MD.0000000000023323. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality rate related to treatment	60 days
Primary	Morbidity	Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system	60 days
Primary	Total morbidity	Morbidity calculated by means of the Comprehensive Complication Index	60 days
Secondary	Upfront Hartmann rate	Observed to expected (O:E) ratio of Hartmann's procedures	60 days
Secondary	Length of stay (LOS)	Days of stay as inpatient	60 days
Secondary	ICU length of stay	Days of stay in ICU	60 days