Scandinavian Diverticulitis Trial SCANDIV-II

Diverticulitis Colon Clinical Trial

— SCANDIV-II  

Official title:

Scandinavian Diverticulitis Trial SCANDIV II: Treatment of Acute Complicated Diverticulitis: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254224
• Other study ID #: 2017/448
• Status: Recruiting
• Start date: April 10, 2018
• Est. completion date: September 10, 2024

Study information

• Verified date: February 2020
• Source: Uppsala University
• Contact: Johanna M Sigurdardottir, MD
• Phone: 004621173000
• Email: johanna.sigurdardottir[@]regionvastmanland.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 10, 2024
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• patients with uncomplicated diverticulitis

• unable to give informed consent.

• language barrier

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulitis Colon
• Diverticulitis, Colonic

Intervention

Procedure:
• colon resection, stoma
oral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage

Locations

Country	Name	City	State
Sweden	Region Vastmanland Hospital	Västerås	Västmanland

Sponsors (8)

Lead Sponsor	Collaborator
Uppsala University	Centrallasarettet Västerås, Danderyd Hospital, Mora Hospital, Landstinget Dalarna, Sahlgrenska University Hospital, Sweden, Stockholm South General Hospital, University Hospital, Linkoeping, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (17)

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. Epub 2006 Jan 7. Review. — View Citation

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. Epub 2001 Nov 8. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Woods RJ, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Internal fistulas in diverticular disease. Dis Colon Rectum. 1988 Aug;31(8):591-6. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment in complicated diverticulitis	Surgery or conservative managment	1year
Primary	Treatment failure	Complications, reoperation, readmission, recurrence , mortality	1year
Secondary	Evaluation of guality of Life	Quality of Life according to Short Health Scale Likert-scale.	1 years
Secondary	Evaluation of guality of Life	Quality of Life according to GIQLI.	1 years
Secondary	Evaluation of guality of Life	Quality of Life according to EQ5D.	1 years
Secondary	Stoma	Proportion of patients with Stoma	1 year