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DiverticulitisDACSCODNCT03337984

Damage Control Surgery in the Treatment of Complicated Diverticulitis

An observational study of Diverticulitis, run by University of Roma La Sapienza at 9 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diverticulitis
How many people
121 participants
Where
9 sitesItaly
Study dates
1 Sep 2017to 30 Dec 2020
How long will I take part?
6 Months
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Patients operated on for Hinchey III or IV class and treated by damage control surgery procedure

Who may be able to join

  • Patients undergoing surgery for Hinchey III and IV stage scheduled for immediate Hartmann's procedure and ICU recovery

Who cannot join

  • None

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • Policlinico Abano Terme

    Abano Terme, Veneto, 35031

  • Ospedale Civile di Adria

    Adria, Rovigo

  • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

    Ancona, The Marches, 60121

  • Ospedale San Donato

    Arezzo, Tuscany, 52100

  • Ospedale San Giovanni Battista

    Foligno, Umbria, 06034

  • Azienda Ospedaliera Cardarelli

    Naples, Campania

  • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

    Pisa, Tuscany, 56121

  • Policlinico San Pietro

    Ponte San Pietro, Bergamo

  • Azienda Ospedaliera Santa Maria

    Terni, Umbria

Other trials in Italy

About this study

Official title: Damage Control Surgery in the Treatment of Hinchey Stage III and IV Diverticulitis: an Italian Nationwide Survey

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

Read the detailed 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

Conditions
Diverticulitis
Keywords
Diverticulitis, Damage Control Surgery
Medical subject headings
Diverticulitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Mortality rate related to treatment

    Measured: 6 months

Secondary outcomes (4)

  1. Morbidity

    Complications rate arranged by Clavien-Dindo classification I to IV

    Measured: 6 months

  2. Lenght of stay (LOS)

    Days of stay as inpatient

    Measured: 6 months

  3. ICU lenght of stay

    Days of stay as

    Measured: 12 months

  4. Number of Hartmann's procedure

    Observed to expected (O:E) ratio of Hartmann's procedures

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2017
  2. Study start1 Sep 2017
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

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
Case only
Time perspective
Other
Enrolment
121 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337984
Sponsor's protocol ID
EM-SURG AOSA 2017_1
Acronym
DACSCOD
Status last verified
May 2021
First submitted
12 Jun 2017
Last updated
18 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will probably be shared with other researchers

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.

    PubMed 25170867

  • 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.

    PubMed 22356208

  • 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.

    PubMed 23222283

  • 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.

    PubMed 29035926

  • 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.

    PubMed 28948335

  • 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.

    PubMed 26808023

  • 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.

    PubMed 24273018

  • 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.

    PubMed 23928745

  • 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.

    PubMed 21146021

  • 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.

    PubMed 25437034

  • 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.

    PubMed 28748737

  • 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.

    PubMed 28943323

  • 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.

    PubMed 28814969

  • 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.

    PubMed 22843083

  • 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.

    PubMed 20148255

Questions about this trial

What is this clinical trial studying?

An observational study of Diverticulitis, run by University of Roma La Sapienza at 9 sites in Italy.

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: finished, as of the sponsor's last update on 18 May 2021. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 6 months). 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 NCT03337984, which also lists 20 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 18 May 2021.

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