NCT04254224

Brief Summary

This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV. The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Furthermore, the effects on quality of life for this patient group will be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

September 20, 2019

Last Update Submit

February 2, 2020

Conditions

Diverticulitis Colon

Keywords

DiverticulitisSurgeryHincheyTreatmentQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Treatment in complicated diverticulitis

    Surgery or conservative managment

    1year

  • Treatment failure

    Complications, reoperation, readmission, recurrence , mortality

    1year

Secondary Outcomes (4)

  • Evaluation of guality of Life

    1 years

  • Evaluation of guality of Life

    1 years

  • Evaluation of guality of Life

    1 years

  • Stoma

    1 year

Study Arms (1)

Diverticulitis Hinchey I-IV

Patients with complicated diverticulitis (Hinchey I-IV) treated conservatively (iv antibiotics with or without percutaneous, transrectal or transvaginal drainage) or surgically.

Procedure: colon resection, stoma

Interventions

colon resection, stomaPROCEDURE

oral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage

Also known as: Conservative treatment
Diverticulitis Hinchey I-IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients 18 years and older with complicated diverticulitis that are admitted to hospital. Diagnosis verified with computed tomography.

You may qualify if:

  • Age ≥18 years
  • Clinical symptoms and laboratory results suspicious for diverticulitis
  • CT findings of complicated diverticulitis with extraluminal air, presence of abscess with or without fistula or operative findings of complicated diverticulitis in an emergency setting

You may not qualify if:

  • patients with uncomplicated diverticulitis
  • unable to give informed consent.
  • language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Vastmanland Hospital

Västerås, Västmanland County, 721 89, Sweden

RECRUITING

Related Publications (17)

  • Etzioni DA, Mack TM, Beart RW Jr, Kaiser AM. Diverticulitis in the United States: 1998-2005: changing patterns of disease and treatment. Ann Surg. 2009 Feb;249(2):210-7. doi: 10.1097/SLA.0b013e3181952888.

    PMID: 19212172BACKGROUND

  • Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, Gemmen E, Shah S, Avdic A, Rubin R. The burden of selected digestive diseases in the United States. Gastroenterology. 2002 May;122(5):1500-11. doi: 10.1053/gast.2002.32978.

    PMID: 11984534BACKGROUND

  • Heise CP. Epidemiology and pathogenesis of diverticular disease. J Gastrointest Surg. 2008 Aug;12(8):1309-11. doi: 10.1007/s11605-008-0492-0. Epub 2008 Feb 16.

    PMID: 18278535BACKGROUND

  • Shahedi K, Fuller G, Bolus R, Cohen E, Vu M, Shah R, Agarwal N, Kaneshiro M, Atia M, Sheen V, Kurzbard N, van Oijen MG, Yen L, Hodgkins P, Erder MH, Spiegel B. Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1609-13. doi: 10.1016/j.cgh.2013.06.020. Epub 2013 Jul 12.

    PMID: 23856358BACKGROUND

  • Morris AM, Regenbogen SE, Hardiman KM, Hendren S. Sigmoid diverticulitis: a systematic review. JAMA. 2014 Jan 15;311(3):287-97. doi: 10.1001/jama.2013.282025.

    PMID: 24430321BACKGROUND

  • Abbas S. Resection and primary anastomosis in acute complicated diverticulitis, a systematic review of the literature. Int J Colorectal Dis. 2007 Apr;22(4):351-7. doi: 10.1007/s00384-005-0059-4. Epub 2006 Jan 7.

    PMID: 16437211BACKGROUND

  • Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.

    PMID: 24509449BACKGROUND

  • Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.

    PMID: 735943BACKGROUND

  • Ambrosetti P, Becker C, Terrier F. Colonic diverticulitis: impact of imaging on surgical management -- a prospective study of 542 patients. Eur Radiol. 2002 May;12(5):1145-9. doi: 10.1007/s00330-001-1143-y. Epub 2001 Nov 8.

    PMID: 11976860BACKGROUND

  • Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, Essani R, Beart RW Jr. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol. 2005 Apr;100(4):910-7. doi: 10.1111/j.1572-0241.2005.41154.x.

    PMID: 15784040BACKGROUND

  • Angenete E, Bock D, Rosenberg J, Haglind E. Laparoscopic lavage is superior to colon resection for perforated purulent diverticulitis-a meta-analysis. Int J Colorectal Dis. 2017 Feb;32(2):163-169. doi: 10.1007/s00384-016-2636-0. Epub 2016 Aug 27.

    PMID: 27567926BACKGROUND

  • Ceresoli M, Coccolini F, Montori G, Catena F, Sartelli M, Ansaloni L. Laparoscopic lavage versus resection in perforated diverticulitis with purulent peritonitis: a meta-analysis of randomized controlled trials. World J Emerg Surg. 2016 Aug 30;11(1):42. doi: 10.1186/s13017-016-0103-4. eCollection 2016.

    PMID: 27582782BACKGROUND

  • Cirocchi R, Di Saverio S, Weber DG, Tabola R, Abraha I, Randolph J, Arezzo A, Binda GA. Laparoscopic lavage versus surgical resection for acute diverticulitis with generalised peritonitis: a systematic review and meta-analysis. Tech Coloproctol. 2017 Feb;21(2):93-110. doi: 10.1007/s10151-017-1585-0. Epub 2017 Feb 15.

    PMID: 28197792BACKGROUND

  • Marshall JR, Buchwald PL, Gandhi J, Schultz JK, Hider PN, Frizelle FA, Eglinton TW. Laparoscopic Lavage in the Management of Hinchey Grade III Diverticulitis: A Systematic Review. Ann Surg. 2017 Apr;265(4):670-676. doi: 10.1097/SLA.0000000000002005.

    PMID: 27631772BACKGROUND

  • Elliott PA, McLemore EC, Abbass MA, Abbas MA. Robotic versus laparoscopic resection for sigmoid diverticulitis with fistula. J Robot Surg. 2015 Jun;9(2):137-42. doi: 10.1007/s11701-015-0503-6. Epub 2015 Feb 26.

    PMID: 26531114BACKGROUND

  • Woods RJ, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Internal fistulas in diverticular disease. Dis Colon Rectum. 1988 Aug;31(8):591-6. doi: 10.1007/BF02556792.

    PMID: 3402284BACKGROUND

  • Thorisson A, Nikberg M, Andreasson K, Smedh K, Chabok A. Non-operative management of perforated diverticulitis with extraluminal or free air - a retrospective single center cohort study. Scand J Gastroenterol. 2018 Oct-Nov;53(10-11):1298-1303. doi: 10.1080/00365521.2018.1520291. Epub 2018 Oct 24.

    PMID: 30353758BACKGROUND

MeSH Terms

Conditions

Diverticulitis, ColonicDiverticulitis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesDiverticulosis, ColonicColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Abbas Chabok, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna M Sigurdardottir, MD

CONTACT

004621173000johanna.sigurdardottir@regionvastmanland.se

Maziar Nikberg, MD, PhD

CONTACT

004621173000maziar.nikberg@regionvastmanland.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. prof. Abbas Chabok Head of colorectal unit Surgical department Västmanlands Hospital and Centre for clinical research Uppsala University

Study Record Dates

First Submitted

September 20, 2019

First Posted

February 5, 2020

Study Start

April 10, 2018

Primary Completion

April 10, 2022

Study Completion

September 10, 2024

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

SE(1)