Diverticular PerforationDACOSADNCT06428370
Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)
An observational study of Diverticular Perforation and Open Abdomen, run by Link Campus University at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Perforation, Open Abdomen
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Jan 2020to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Same as above
Who may be able to join
- Patients >18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen
Who cannot join
- Subjects <18 year-old
Trial locations and contacts
9 sites in 2 countries.
Giuseppina Catanzaro, Prof. contact
9 sites in 2 countries
Italy8 sites, 8 recruiting
- Recruiting
UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano
Caserta, 81100
Mauro Andreano, Prof.
Alberto Mingione, MD
- Recruiting
UOC Chirurgia Generale - Ospedale GB Grassi
Ostia Antica, Roma, 00122
Gianluca Mazzoni, MD, PhD
Anna Maria Bellotti, MD, annamaria.bellotti@aslroma3.it
- Recruiting
UOC Chirurgia Generale Ospedale Coniugi Bernardini
Palestrina, Roma, 00036
Gianluca Liotta, MD, PhD, +39 06 95321
- Recruiting
UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital
Pisa, 56124
Massimo Chiarugi, MD, FACS
Dario Tartaglia, MD
- Recruiting
Fondazione Policlinico Universitario "A.Gemelli"
Roma, 00168
Gabriele Sganga, MD, FACS
Pietro Fransvea, MD
- Recruiting
UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia
Roma, 00193
Luca Lepre, MD, PhD
Michela Giulii Capponi, MD
- Recruiting
Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma
Roma
Andrea Mingoli, Prof.
Gioia Brachini, MD, PhD
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00128
Marco Caricato, MD, PhD
Gabriella T Capolupo, MD, PhD
Chile1 site, 1 recruiting
- Enrolling by invitation
Hospital de Urgencia Asistencia Publica
Santiago
About this study
Official title: 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.
Read the 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
- Being tested
- Damage Control Surgery
- Keywords
- Diverticulitis, Surgery, Open abdomen, Septic shock
- Medical subject headings
- Diverticulitis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damage Control SurgeryProcedure or surgery
Simple resection, drop, and open abdomen in case of Hinchey III-IV
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate related to treatment
Measured: 60 days
Morbidity
Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system
Measured: 60 days
Total morbidity
Morbidity calculated by means of the Comprehensive Complication Index
Measured: 60 days
Secondary outcomes (3)
Upfront Hartmann rate
Observed to expected (O:E) ratio of Hartmann's procedures
Measured: 60 days
Length of stay (LOS)
Days of stay as inpatient
Measured: 60 days
ICU length of stay
Days of stay in ICU
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diverticular PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Link Campus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluca Costa, Prof., Study director, Link Campus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428370
- Sponsor's protocol ID
- LCU MEDS-06/A 01/2024
- Acronym
- DACOSAD
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perrone G, Giuffrida M, Abu-Zidan F, Kruger VF, Livrini M, Petracca GL, Rossi G, Tarasconi A, Tian BWCA, Bonati E, Mentz R, Mazzini FN, Campana JP, Gasser E, Kafka-Ritsch R, Felsenreich DM, Dawoud C, Riss S, Gomes CA, Gomes FC, Gonzaga RAT, Canton CAB, Pereira BM, Fraga GP, Zem LG, Cordeiro-Fonseca V, de Mesquita Tauil R, Atanasov B, Belev N, Kovachev N, Melendez LJJ, Dimova A, Dimov S, Zelic Z, Augustin G, Bogdanic B, Moric T, Chouillard E, Bajul M, De Simone B, Panis Y, Esposito F, Notarnicola M, Lauka L, Fabbri A, Hentati H, Fnaiech I, Aurelien V, Bougard M, Roulet M, Demetrashvili Z, Pipia I, Merabishvili G, Bouliaris K, Koukoulis G, Doudakmanis C, Xenaki S, Chrysos E, Kokkinakis S, Vassiliu P, Michalopoulos N, Margaris I, Kechagias A, Avgerinos K, Katunin J, Lostoridis E, Nagorni EA, Pujante A, Mulita F, Maroulis I, Vailas M, Marinis A, Siannis I, Bourbouteli E, Manatakis DK, Tasis N, Acheimastos V, Maria S, Stylianos K, Kuzeridis H, Korkolis D, Fradelos E, Kavalieratos G, Petropoulou T, Polydorou A, Papacostantinou I, Triantafyllou T, Kimpizi D, Theodorou D, Toutouzas K, Chamzin A, Frountzas M, Schizas D, Karavokyros I, Syllaios A, Charalabopoulos A, Boura M, Baili E, Ioannidis O, Loutzidou L, Anestiadou E, Tsouknidas I, Petrakis G, Polenta E, Bains L, Gupta R, Singh SK, Khanduri A, Bala M, Kedar A, Pisano M, Podda M, Pisanu A, Martines G, Trigiante G, Lantone G, Agrusa A, Di Buono G, Buscemi S, Veroux M, Gioco R, Veroux G, Oragano L, Zonta S, Lovisetto F, Feo CV, Pesce A, Fabbri N, Lantone G, Marino F, Perrone F, Vincenti L, Papagni V, Picciariello A, Rossi S, Picardi B, Del Monte SR, Visconti D, Osella G, Petruzzelli L, Pignata G, Andreuccetti J, D'Alessio R, Buonfantino M, Guaitoli E, Spinelli S, Sampietro GM, Corbellini C, Lorusso L, Frontali A, Pezzoli I, Bonomi A, Chierici A, Cotsoglou C, Manca G, Delvecchio A, Musa N, Casati M, Letizia L, Abate E, Ercolani G, D'Acapito F, Solaini L, Guercioni G, Cicconi S, Sasia D, Borghi F, Giraudo G, Sena G, Castaldo P, Cardamone E, Portale G, Zuin M, Spolverato Y, Esposito M, Isernia RM, Di Salvo M, Manunza R, Esposito G, Agus M, Asti ELG, Bernardi DT, Tonucci TP, Luppi D, Casadei M, Bonilauri S, Pezzolla A, Panebianco A, Laforgia R, De Luca M, Zese M, Parini D, Jovine E, De Sario G, Lombardi R, Aprea G, Palomba G, Capuano M, Argenio G, Orio G, Armellino MF, Troian M, Guerra M, Nagliati C, Biloslavo A, Germani P, Aizza G, Monsellato I, Chahrour AC, Anania G, Bombardini C, Bagolini F, Sganga G, Fransvea P, Bianchi V, Boati P, Ferrara F, Palmieri F, Cianci P, Gattulli D, Restini E, Cillara N, Cannavera A, Nita GE, Sarnari J, Roscio F, Clerici F, Scandroglio I, Berti S, Cadeo A, Filippelli A, Conti L, Grassi C, Cattaneo GM, Pighin M, Papis D, Gambino G, Bertino V, Schifano D, Prando D, Fogato L, Cavallo F, Ansaloni L, Picheo R, Pontarolo N, Depalma N, Spampinato M, D'Ugo S, Lepre L, Capponi MG, Campa RD, Sarro G, Dinuzzi VP, Olmi S, Uccelli M, Ferrari D, Inama M, Moretto G, Fontana M, Favi F, Picariello E, Rampini A, Barberis A, Azzinnaro A, Oliva A, Totaro L, Benzoni I, Ranieri V, Capolupo GT, Carannante F, Caricato M, Ronconi M, Casiraghi S, Casole G, Pantalone D, Alemanno G, Scheiterle M, Ceresoli M, Cereda M, Fumagalli C, Zanzi F, Bolzon S, Guerra E, Lecchi F, Cellerino P, Ardito A, Scaramuzzo R, Balla A, Lepiane P, Tartaglia N, Ambrosi A, Pavone G, Palini GM, Veneroni S, Garulli G, Ricci C, Torre B, Russo IS, Rottoli M, Tanzanu M, Belvedere A, Milone M, Manigrasso M, De Palma GD, Piccoli M, Pattacini GC, Magnone S, Bertoli P, Pisano M, Massucco P, Palisi M, Luzzi AP, Fleres F, Clarizia G, Spolini A, Kobe Y, Toma T, Shimamura F, Parker R, Ranketi S, Mitei M, Svagzdys S, Pauzas H, Zilinskas J, Poskus T, Kryzauskas M, Jakubauskas M, Zakaria AD, Zakaria Z, Wong MP, Jusoh AC, Zakaria MN, Cruz DR, Elizalde ABR, Reynaud AB, Hernandez EEL, Monroy JMVP, Hinojosa-Ugarte D, Quiodettis M, Du Bois ME, Latorraca J, Major P, Pedziwiatr M, Pisarska-Adamczyk M, Waledziak M, 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.
PubMed 38627831Cirocchi 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.
PubMed 34557938Sohn 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.
PubMed 33726727Zizzo 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.
PubMed 33235095Khan 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.
PubMed 23928745Pavlidis 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.
PubMed 36176861Tartaglia 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 Surg. 2019 Apr 16;14:19. doi: 10.1186/s13017-019-0238-1. eCollection 2019.
PubMed 31015859Berg 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/s00423-021-02304-8. Epub 2021 Aug 28.
PubMed 34455491Costa 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.
PubMed 25170867Horesh 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 multicenter retrospective study. Surg Endosc. 2018 Dec;32(12):4780-4787. doi: 10.1007/s00464-018-6227-8. Epub 2018 May 15.
PubMed 29766303Horesh 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 study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6.
PubMed 28879552
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD)
- ClinicalTrials.gov ID
- NCT06428370
- Acronym / sponsor ID
- DACOSAD / LCU MEDS-06/A 01/2024
- Conditions
- Diverticular Perforation, Open Abdomen
- Keywords
- Diverticulitis, Surgery, Open abdomen, Septic shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Link Campus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Same as above
Key inclusion criteria (1 listed)
- Patients >18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen
Key exclusion criteria (1 listed)
- Subjects <18 year-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damage Control SurgerySimple resection, drop, and open abdomen in case of Hinchey III-IV | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: 60 days
Mortality rate related to treatment
Morbidity
Time frame: 60 days
Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system
Total morbidity
Time frame: 60 days
Morbidity calculated by means of the Comprehensive Complication Index
3 secondary outcomes
Upfront Hartmann rate
Time frame: 60 days
Length of stay (LOS)
Time frame: 60 days
ICU length of stay
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 38627831Perrone G, Giuffrida M, Abu-Zidan F, Kruger VF, Livrini M, Petracca GL, Rossi G, Tarasconi A, Tian BWCA, Bonati E, Mentz R, Mazzini FN, Campana JP, Gasser E, Kafka-Ritsch R, Felsenreich DM, Dawoud C, Riss S, Gomes CA, Gomes FC, Gonzaga RAT, Canton CAB, Pereira BM, Fraga GP, Zem LG, Cordeiro-Fonseca V, de Mesquita Tauil R, Atanasov B, Belev N, Kovachev N, Melendez LJJ, Dimova A, Dimov S, Zelic Z, Augustin G, Bogdanic B, Moric T, Chouillard E, Bajul M, De Simone B, Panis Y, Esposito F, Notarnicola M, Lauka L, Fabbri A, Hentati H, Fnaiech I, Aurelien V, Bougard M, Roulet M, Demetrashvili Z, Pipia I, Merabishvili G, Bouliaris K, Koukoulis G, Doudakmanis C, Xenaki S, Chrysos E, Kokkinakis S, Vassiliu P, Michalopoulos N, Margaris I, Kechagias A, Avgerinos K, Katunin J, Lostoridis E, Nagorni EA, Pujante A, Mulita F, Maroulis I, Vailas M, Marinis A, Siannis I, Bourbouteli E, Manatakis DK, Tasis N, Acheimastos V, Maria S, Stylianos K, Kuzeridis H, Korkolis D, Fradelos E, Kavalieratos G, Petropoulou T, Polydorou A, Papacostantinou I, Triantafyllou T, Kimpizi D, Theodorou D, Toutouzas K, Chamzin A, Frountzas M, Schizas D, Karavokyros I, Syllaios A, Charalabopoulos A, Boura M, Baili E, Ioannidis O, Loutzidou L, Anestiadou E, Tsouknidas I, Petrakis G, Polenta E, Bains L, Gupta R, Singh SK, Khanduri A, Bala M, Kedar A, Pisano M, Podda M, Pisanu A, Martines G, Trigiante G, Lantone G, Agrusa A, Di Buono G, Buscemi S, Veroux M, Gioco R, Veroux G, Oragano L, Zonta S, Lovisetto F, Feo CV, Pesce A, Fabbri N, Lantone G, Marino F, Perrone F, Vincenti L, Papagni V, Picciariello A, Rossi S, Picardi B, Del Monte SR, Visconti D, Osella G, Petruzzelli L, Pignata G, Andreuccetti J, D'Alessio R, Buonfantino M, Guaitoli E, Spinelli S, Sampietro GM, Corbellini C, Lorusso L, Frontali A, Pezzoli I, Bonomi A, Chierici A, Cotsoglou C, Manca G, Delvecchio A, Musa N, Casati M, Letizia L, Abate E, Ercolani G, D'Acapito F, Solaini L, Guercioni G, Cicconi S, Sasia D, Borghi F, Giraudo G, Sena G, Castaldo P, Cardamone E, Portale G, Zuin M, Spolverato Y, Esposito M, Isernia RM, Di Salvo M, Manunza R, Esposito G, Agus M, Asti ELG, Bernardi DT, Tonucci TP, Luppi D, Casadei M, Bonilauri S, Pezzolla A, Panebianco A, Laforgia R, De Luca M, Zese M, Parini D, Jovine E, De Sario G, Lombardi R, Aprea G, Palomba G, Capuano M, Argenio G, Orio G, Armellino MF, Troian M, Guerra M, Nagliati C, Biloslavo A, Germani P, Aizza G, Monsellato I, Chahrour AC, Anania G, Bombardini C, Bagolini F, Sganga G, Fransvea P, Bianchi V, Boati P, Ferrara F, Palmieri F, Cianci P, Gattulli D, Restini E, Cillara N, Cannavera A, Nita GE, Sarnari J, Roscio F, Clerici F, Scandroglio I, Berti S, Cadeo A, Filippelli A, Conti L, Grassi C, Cattaneo GM, Pighin M, Papis D, Gambino G, Bertino V, Schifano D, Prando D, Fogato L, Cavallo F, Ansaloni L, Picheo R, Pontarolo N, Depalma N, Spampinato M, D'Ugo S, Lepre L, Capponi MG, Campa RD, Sarro G, Dinuzzi VP, Olmi S, Uccelli M, Ferrari D, Inama M, 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Pisarska-Adamczyk M, Waledziak M, 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.
- Background: PubMed 34557938Cirocchi 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.
- Background: PubMed 33726727Sohn 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.
- Background: PubMed 33235095Zizzo 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.
- Background: PubMed 23928745Khan 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.
- Results publication: PubMed 36176861Pavlidis 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.
- Results publication: PubMed 31015859Tartaglia 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 Surg. 2019 Apr 16;14:19. doi: 10.1186/s13017-019-0238-1. eCollection 2019.
- Results publication: PubMed 34455491Berg 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/s00423-021-02304-8. Epub 2021 Aug 28.
- Results publication: PubMed 25170867Costa 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.
- Results publication: PubMed 29766303Horesh 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 multicenter retrospective study. Surg Endosc. 2018 Dec;32(12):4780-4787. doi: 10.1007/s00464-018-6227-8. Epub 2018 May 15.
- Results publication: PubMed 28879552Horesh 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 study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6.
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Diverticulitis, Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppina Catanzaro, Prof. contact
Gianluca Costa, Prof. study director
Link Campus University
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Perforation and Open Abdomen, run by Link Campus University at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Costa, Prof. (+39 06 22541 8851, g.costa@unilink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428370, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.