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CompletedNCT04254224SCANDIV-IIUpdated Oct 2, 2026

Scandinavian Diverticulitis Trial SCANDIV-II

An observational study in Diverticulitis Colon, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Uppsala University · Observational

Updated Oct 2, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Diverticular disease is among the five most common gastrointestinal disorders. Among individuals with diverticulosis the lifetime risk of suffering from diverticulitis is between 4 and 25%. The most common complications of diverticulitis are perforation, abscess formation, fistula and obstruction. Emergency surgery is necessary in up to 25% of diverticulitis patients.

The American Society of Colon and Rectal Surgeon (ASCRS, 2014) recommends abscess drainage and antibiotic treatment and later elective surgery as treatment for complicated diverticulitis, Hinchey I and II (*) for abscesses larger or equal to 5 cm while others recommend resection surgery only for Hinchey II patients. The recommendations for surgery are motivated by the belief that surgical treatment will reduce the risk for relapsing disease with intra-abdominal/pelvic sepsis by more than 40%. However, these recommendations are based on small and out-dated retrospective studies.

Perforated diverticulitis with radiologically confirmed free intraperitoneal air is a life threatening disease with significant mortality and morbidity therefore several guidelines recommend acute surgical intervention. However, a conservative non-surgical approach for the treatment of perforated diverticulitis has been shown to be effective for hemodynamically stable patients with radiologically confirmed free air. A Swedish study recently showed the incidence of complicated diverticulitis to be 9/100.000 inhabitants/year of which about one third required acute surgical intervention. The most common operation in perforated diverticulitis is Hartman's procedure, which involves removal of the involved sigmoid segment, a terminal colostomy and blind closure of the rectal stump. Also primary resection of the sigmoid colon with anastomosis is frequently used, sometimes combined with a loop-ileostomy. Laparoscopic lavage without resection has emerged as an alternative operation method. However, the SCANDIV trial showed limitations of laparoscopic lavage with a higher frequency of re-operation in the lavage group compared to primary resection after 90 days. Nevertheless, several meta-analysis based on three randomized studies showed comparable rates regarding overall mortality and morbidity in laparoscopic lavage versus resection in perforated diverticulitis.

For patients with diverticulitis complicated by fistula (colovesical, colovaginal or colo cutaneous) surgery is the recommended treatment. This condition, however, rarely presents in an acute setting.

In Scandinavia a conservative approach restricted to antibiotics and percutaneous drainage is widely accepted as solitary treatment for patients with diverticular abscesses (Hinchey I and II). Also hemodynamically stable and non-immunocompromised patients with perforated diverticulitis (Hinchey III) are often managed conservatively with antibiotics and, if required, percutaneous drainage. Acute surgical intervention is performed if the condition of the patient deteriorates during hospital stay or if the CT shows signs of faecal peritonitis (Hinchey IV). Elective surgery for patients after an episode of acute complicated diverticulitis (Hinchey I-III) is usually reserved for patients with frequent relapses or with a persisting diverticular abscess.

However, some patients have frequent relapses with abscesses which are difficult to treat and suffer for a long time until the problem is solved. This clinical experience raises the question whether the Scandinavian treatment policy might be too conservative sometimes. Although elective surgery itself can lead to new complications and eventual deterioration in quality of life, early resection might be a better option for some patients. Also the quality of life for patients after conservative management of complicated diverticulitis has not been examined in detail previously.

* I Pericolic abscess II Distant/pelvic abscess III Generalized purulent peritonitis IV Faecal peritonitis

02

Conditions studied

  • Diverticulitis Colon

Keywords

  • Diverticulitis
  • Surgery
  • Hinchey
  • Treatment
  • Quality of Life
03

In context

Diverticulitis, Colonic

27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.

This study's enrollment of 500 is above the median of 250 across 15 observational studies indexed under Diverticulitis, Colonic.

Browse Diverticulitis, Colonic studies →

Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • patients with uncomplicated diverticulitis
  • unable to give .
  • language barrier
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurecolon resection, stoma

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

    Also known as: Conservative treatment

06

What researchers measure

Primary outcomes

  1. Treatment in complicated diverticulitis

    Surgery or conservative managment

    Time frame: 1year

  2. Treatment failure

    Complications, reoperation, readmission, recurrence , mortality

    Time frame: 1year

Secondary outcomes

  1. Evaluation of guality of Life

    Quality of Life according to Short Health Scale Likert-scale.

    Time frame: 1 years

  2. Evaluation of guality of Life

    Quality of Life according to GIQLI.

    Time frame: 1 years

  3. Evaluation of guality of Life

    Quality of Life according to EQ5D.

    Time frame: 1 years

  4. Stoma

    Proportion of patients with Stoma

    Time frame: 1 year

07

Study locations

1 site
  • Region Vastmanland Hospital
    Västerås, Västmanland County 721 89, Sweden
08

References and documents

Publications

  • 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. PubMed 19212172 ↗
  • 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. PubMed 11984534 ↗
  • 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. PubMed 18278535 ↗
  • 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. PubMed 23856358 ↗
  • 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. PubMed 24430321 ↗
  • 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. PubMed 16437211 ↗
  • 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. PubMed 24509449 ↗
  • Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109. PubMed 735943 ↗
  • 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. PubMed 11976860 ↗
  • 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. PubMed 15784040 ↗
  • 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. PubMed 27567926 ↗
  • 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. PubMed 27582782 ↗
  • 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. PubMed 28197792 ↗
  • 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. PubMed 27631772 ↗
  • 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. PubMed 26531114 ↗
  • 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. PubMed 3402284 ↗
  • 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. PubMed 30353758 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Completed
changed Oct 2, 2026
Sites
1 site added, 1 site removed
Show site
  • Region Vastmanland Hospital · Västerås, Sweden
Show 1 removed
  • Region Vastmanland Hospital · Västerås, Sweden
Oct 2, 2026
Primary completion
Apr 10, 2022→Sep 10, 2026 (actual)
Oct 2, 2026
Study completion
Sep 10, 2024→Sep 10, 2026 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Status unknown→Completed
    1 site added, 1 site removed
    Show site
    • Region Vastmanland Hospital · Västerås, Sweden
    Show 1 removed
    • Region Vastmanland Hospital · Västerås, Sweden
    Primary completion Apr 10, 2022→Sep 10, 2026 (now actual)
    Study completion Sep 10, 2024→Sep 10, 2026 (now actual)
    + 4 other changes: verification date, responsible party, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04254224
Lead sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna, Uppsala University Hospital, University Hospital, Linkoeping, Danderyd Hospital, Sahlgrenska University Hospital, Stockholm South General Hospital
Responsible party
Abbas Chabok MD (Ass. prof. Abbas Chabok Head of colorectal unit Surgical department Västmanlands Hospital and Centre for clinical research Uppsala University, Uppsala University) — Principal investigator
First posted
Feb 5, 2020
Start date
Apr 10, 2018
Primary completion
Sep 10, 2026
Completion
Sep 10, 2026
Last update
Oct 2, 2026

Study contacts

Abbas Chabok, MD, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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