Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337984
Other study ID # EM-SURG AOSA 2017_1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 30, 2020

Study information

Verified date May 2021
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of Hinchey III or IV diverticulitis.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing surgery for Hinchey III and IV stage scheduled for immediate Hartmann's procedure and ICU recovery Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Policlinico Abano Terme Abano Terme Veneto
Italy Ospedale Civile di Adria Adria Rovigo
Italy Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona Ancona Marche
Italy Ospedale San Donato Arezzo Toscana
Italy Ospedale San Giovanni Battista Foligno Umbria
Italy Azienda Ospedaliera Cardarelli Napoli Campania
Italy Azienda Ospedaliera Pisana Policlinico Universitario Cisanello Pisa Toscana
Italy Policlinico San Pietro Ponte San Pietro Bergamo
Italy Azienda Ospedaliera Santa Maria Terni Umbria

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (20)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — 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

Girard E, Abba J, Boussat B, Trilling B, Mancini A, Bouzat P, Létoublon 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. — View Citation

Hess GF, Schäfer 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. — 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 study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6. — View Citation

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. — View Citation

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. Epub 2012 Jul 28. — 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

Perathoner A, Klaus A, Mühlmann 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality rate related to treatment 6 months
Secondary Morbidity Complications rate arranged by Clavien-Dindo classification I to IV 6 months
Secondary Lenght of stay (LOS) Days of stay as inpatient 6 months
Secondary ICU lenght of stay Days of stay as 12 months
Secondary Number of Hartmann's procedure Observed to expected (O:E) ratio of Hartmann's procedures 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01081054 - Hospitalization or Ambulatory Treatment of Acute Diverticulitis Phase 4
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Recruiting NCT06210724 - FIT in Diverticulitis
Completed NCT01986686 - Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis N/A
Completed NCT01477190 - Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program Phase 1/Phase 2
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Enrolling by invitation NCT03700593 - Feasibility and Safety of Single Port Robot in Colorectal Procedures
Recruiting NCT04095663 - Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial N/A
Completed NCT00545740 - Prevention of Recurrence of Diverticulitis Phase 3
Recruiting NCT01837342 - Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery N/A
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT00554099 - Asacol Acute Diverticulitis(DIVA)Study Phase 2
Completed NCT04173182 - Confocal Laser Endomicrospy in Colonic Diverticular Disease
Completed NCT02200055 - Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need N/A
Completed NCT01560377 - Perfusion Assessment in Laparoscopic Left Anterior Resection Phase 1