Damage Control Surgery in the Treatment of Complicated Diverticulitis
NCT ID: NCT03337984
Last Updated: 2021-05-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
121 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-09-01
Study Completion Date
2020-12-30
Brief Summary
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To evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of Hinchey III or IV diverticulitis.
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Detailed Description
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Despite the progress in the resuscitation modalities of septic patients, Hartmann procedure (HP) is still considered the safest treatment for generalized peritonitis as a consequence of a complicated acute diverticulitis (stages III and IV of the Hinchey's classification). Almost the half of those patients do not have their stoma reversed because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) is a matter of debate, as it is reported in the literature that it is substantially equivalent to HP in terms of morbidity and length of postoperative stay. For these reason, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination. In the last decade, Damage Control Surgery has been emerging as a valid alternative to HP and RA in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Initially described for the treatment of major abdominal injuries, indications for DCS have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. However, there is still no consensus about the use of DCS in perforated acute diverticulitis.
The aim of this study was to describe "how-to-use" the Damage Control Surgery in patients with purulent and fecal peritonitis following a severe acute diverticulitis and report the impact on patients' outcomes after the application of this technique in several Italian centers of emergency surgery
The aim of this study was to describe "how-to-use" the Damage Control Surgery in patients with purulent and fecal peritonitis following a severe acute diverticulitis and report the impact on patients' outcomes after the application of this technique in several Italian centers of emergency surgery
Conditions
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Diverticulitis
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing surgery for Hinchey III and IV stage scheduled for immediate Hartmann's procedure and ICU recovery
Exclusion Criteria
* None
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Roma La Sapienza
OTHER
Sponsor Role
lead
Responsible Party
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Gianluca Costa
Study Creator and Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Gianluca Costa, MD, PhD
Role: STUDY_DIRECTOR
University of Roma La Sapienza, Sant' Andrea University Hospital
Locations
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Policlinico San Pietro
Ponte San Pietro, Bergamo, Italy
Site Status
Azienda Ospedaliera Cardarelli
Napoli, Campania, Italy
Site Status
Ospedale Civile di Adria
Adria, Rovigo, Italy
Site Status
Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
Ancona, The Marches, Italy
Site Status
Ospedale San Donato
Arezzo, Tuscany, Italy
Site Status
Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
Pisa, Tuscany, Italy
Site Status
Ospedale San Giovanni Battista
Foligno, Umbria, Italy
Site Status
Azienda Ospedaliera Santa Maria
Terni, Umbria, Italy
Site Status
Policlinico Abano Terme
Abano Terme, Veneto, Italy
Site Status
Countries
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Italy
References
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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.
Reference Type
BACKGROUND
Ince M, Stocchi L, Khomvilai S, Kwon DS, Hammel JP, Kiran RP. Morbidity and mortality of the Hartmann procedure for diverticular disease over 18 years in a single institution. Colorectal Dis. 2012 Aug;14(8):e492-8. doi: 10.1111/j.1463-1318.2012.03004.x.
Reference Type
BACKGROUND
Turley RS, Barbas AS, Lidsky ME, Mantyh CR, Migaly J, Scarborough JE. Laparoscopic versus open Hartmann procedure for the emergency treatment of diverticulitis: a propensity-matched analysis. Dis Colon Rectum. 2013 Jan;56(1):72-82. doi: 10.1097/DCR.0b013e3182749cf5.
Reference Type
BACKGROUND
Benz D, Balogh ZJ. Damage control surgery: current state and future directions. Curr Opin Crit Care. 2017 Dec;23(6):491-497. doi: 10.1097/MCC.0000000000000465.
Reference Type
BACKGROUND
Girard E, Abba J, Boussat B, Trilling B, Mancini A, Bouzat P, Letoublon C, Chirica M, Arvieux C. Damage Control Surgery for Non-traumatic Abdominal Emergencies. World J Surg. 2018 Apr;42(4):965-973. doi: 10.1007/s00268-017-4262-6.
Reference Type
BACKGROUND
Bruns BR, Ahmad SA, O'Meara L, Tesoriero R, Lauerman M, Klyushnenkova E, Kozar R, Scalea TM, Diaz JJ. Nontrauma open abdomens: A prospective observational study. J Trauma Acute Care Surg. 2016 Apr;80(4):631-6. doi: 10.1097/TA.0000000000000958.
Reference Type
BACKGROUND
Weber DG, Bendinelli C, Balogh ZJ. Damage control surgery for abdominal emergencies. Br J Surg. 2014 Jan;101(1):e109-18. doi: 10.1002/bjs.9360. Epub 2013 Nov 25.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Subramanian A, Balentine C, Palacio CH, Sansgiry S, Berger DH, Awad SS. Outcomes of damage-control celiotomy in elderly nontrauma patients with intra-abdominal catastrophes. Am J Surg. 2010 Dec;200(6):783-8; discussion 788-9. doi: 10.1016/j.amjsurg.2010.07.027.
Reference Type
BACKGROUND
Cirocchi R, Arezzo A, Vettoretto N, Cavaliere D, Farinella E, Renzi C, Cannata G, Desiderio J, Farinacci F, Barberini F, Trastulli S, Parisi A, Fingerhut A. Role of damage control surgery in the treatment of Hinchey III and IV sigmoid diverticulitis: a tailored strategy. Medicine (Baltimore). 2014 Nov;93(25):e184. doi: 10.1097/MD.0000000000000184.
Reference Type
BACKGROUND
Cassini D, Miccini M, Manoochehri F, Gregori M, Baldazzi G. Emergency Hartmann's Procedure and Its Reversal: A Totally Laparoscopic 2-Step Surgery for the Treatment of Hinchey III and IV Diverticulitis. Surg Innov. 2017 Dec;24(6):557-565. doi: 10.1177/1553350617722226. Epub 2017 Jul 27.
Reference Type
BACKGROUND
Bridoux V, Regimbeau JM, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Schwarz L, Mege D, Sielezneff I, Sabbagh C, Tuech JJ. Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI). J Am Coll Surg. 2017 Dec;225(6):798-805. doi: 10.1016/j.jamcollsurg.2017.09.004. Epub 2017 Sep 22.
Reference Type
BACKGROUND
Coccolini F, Montori G, Ceresoli M, Catena F, Moore EE, Ivatury R, Biffl W, Peitzman A, Coimbra R, Rizoli S, Kluger Y, Abu-Zidan FM, Sartelli M, De Moya M, Velmahos G, Fraga GP, Pereira BM, Leppaniemi A, Boermeester MA, Kirkpatrick AW, Maier R, Bala M, Sakakushev B, Khokha V, Malbrain M, Agnoletti V, Martin-Loeches I, Sugrue M, Di Saverio S, Griffiths E, Soreide K, Mazuski JE, May AK, Montravers P, Melotti RM, Pisano M, Salvetti F, Marchesi G, Valetti TM, Scalea T, Chiara O, Kashuk JL, Ansaloni L. The role of open abdomen in non-trauma patient: WSES Consensus Paper. World J Emerg Surg. 2017 Aug 14;12:39. doi: 10.1186/s13017-017-0146-1. eCollection 2017.
Reference Type
BACKGROUND
Kafka-Ritsch R, Birkfellner F, Perathoner A, Raab H, Nehoda H, Pratschke J, Zitt M. Damage control surgery with abdominal vacuum and delayed bowel reconstruction in patients with perforated diverticulitis Hinchey III/IV. J Gastrointest Surg. 2012 Oct;16(10):1915-22. doi: 10.1007/s11605-012-1977-4. Epub 2012 Jul 28.
Reference Type
BACKGROUND
Perathoner A, Klaus A, Muhlmann G, Oberwalder M, Margreiter R, Kafka-Ritsch R. Damage control with abdominal vacuum therapy (VAC) to manage perforated diverticulitis with advanced generalized peritonitis--a proof of concept. Int J Colorectal Dis. 2010 Jun;25(6):767-74. doi: 10.1007/s00384-010-0887-8. Epub 2010 Feb 11.
Reference Type
BACKGROUND
Sohn M, Agha A, Heitland W, Gundling F, Steiner P, Iesalnieks I. Damage control strategy for the treatment of perforated diverticulitis with generalized peritonitis. Tech Coloproctol. 2016 Aug;20(8):577-83. doi: 10.1007/s10151-016-1506-7. Epub 2016 Jul 22.
Reference Type
BACKGROUND
Hess GF, Schafer J, Rosenthal R, Kettelhack C, Oertli D. Reversal after Hartmann's procedure in patients with complicated sigmoid diverticulitis. Colorectal Dis. 2017 Jun;19(6):582-588. doi: 10.1111/codi.13553.
Reference Type
BACKGROUND
Vennix S, Boersema GS, Buskens CJ, Menon AG, Tanis PJ, Lange JF, Bemelman WA. Emergency Laparoscopic Sigmoidectomy for Perforated Diverticulitis with Generalised Peritonitis: A Systematic Review. Dig Surg. 2016;33(1):1-7. doi: 10.1159/000441150. Epub 2015 Nov 10.
Reference Type
BACKGROUND
Richards CH, Roxburgh CS; Scottish Surgical Research Group (SSRG). Surgical outcome in patients undergoing reversal of Hartmann's procedures: a multicentre study. Colorectal Dis. 2015 Mar;17(3):242-9. doi: 10.1111/codi.12807.
Reference Type
BACKGROUND
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 study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6.
Reference Type
BACKGROUND
Other Identifiers
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EM-SURG AOSA 2017_1
Identifier Type: -
Identifier Source: org_study_id
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