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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02003807
Other study ID # 4-2013-0326
Secondary ID
Status Completed
Phase N/A
First received December 2, 2013
Last updated December 2, 2013
Start date July 2013
Est. completion date September 2013

Study information

Verified date December 2013
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. We thought that post diverticulitis status could induce IBS because diverticulitis was also bowel inflammatory disorder. This survey was designed to identify incidence of post-diverticulitis IBS and risk factor in Korea.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 20 years or over

- Patients who diagnosed diverticulitis by CT scan from 2006 to 2010 (Case)

- Patients who admitted to hospital because of non-gastrointestinal disorder (Control)

Exclusion Criteria:

- Patients who diagnosed IBS before diverticulitis (Case)

- Patients who diagnosed IBS before admission (Control)

- Patients with bowel resection surgery except for laparoscopic appendectomy

- Pregnancy

- Do not agree the consent of this study

- Patients who dose not understand telephone survey such as foreigner, mental retardation.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

Ballou SK, Keefer L. Multicultural considerations in the diagnosis and management of irritable bowel syndrome: a selective summary. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1127-33. doi: 10.1097/MEG.0b013e3283632bf2. Review. — View Citation

Cohen E, Fuller G, Bolus R, Modi R, Vu M, Shahedi K, Shah R, Atia M, Kurzbard N, Sheen V, Agarwal N, Kaneshiro M, Yen L, Hodgkins P, Erder MH, Spiegel B. Increased risk for irritable bowel syndrome after acute diverticulitis. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1614-9. doi: 10.1016/j.cgh.2013.03.007. Epub 2013 Mar 21. — View Citation

Hammond NA, Nikolaidis P, Miller FH. Left lower-quadrant pain: guidelines from the American College of Radiology appropriateness criteria. Am Fam Physician. 2010 Oct 1;82(7):766-70. Review. — View Citation

Hughes PA, Zola H, Penttila IA, Blackshaw LA, Andrews JM, Krumbiegel D. Immune activation in irritable bowel syndrome: can neuroimmune interactions explain symptoms? Am J Gastroenterol. 2013 Jul;108(7):1066-74. doi: 10.1038/ajg.2013.120. Epub 2013 May 7. Review. — View Citation

Ishihara S, Tada Y, Fukuba N, Oka A, Kusunoki R, Mishima Y, Oshima N, Moriyama I, Yuki T, Kawashima K, Kinoshita Y. Pathogenesis of irritable bowel syndrome--review regarding associated infection and immune activation. Digestion. 2013;87(3):204-11. doi: 10.1159/000350054. Epub 2013 May 23. Review. — View Citation

Ji S, Park H, Lee D, Song YK, Choi JP, Lee SI. Post-infectious irritable bowel syndrome in patients with Shigella infection. J Gastroenterol Hepatol. 2005 Mar;20(3):381-6. — View Citation

Jung IS, Kim HS, Park H, Lee SI. The clinical course of postinfectious irritable bowel syndrome: a five-year follow-up study. J Clin Gastroenterol. 2009 Jul;43(6):534-40. doi: 10.1097/MCG.0b013e31818c87d7. — View Citation

Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15. — View Citation

Ohman L, Simrén M. New insights into the pathogenesis and pathophysiology of irritable bowel syndrome. Dig Liver Dis. 2007 Mar;39(3):201-15. Epub 2007 Jan 30. Review. — View Citation

Rafferty J, Shellito P, Hyman NH, Buie WD; Standards Committee of American Society of Colon and Rectal Surgeons. Practice parameters for sigmoid diverticulitis. Dis Colon Rectum. 2006 Jul;49(7):939-44. — View Citation

Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7. Review. — View Citation

Spiller R. Is it diverticular disease or is it irritable bowel syndrome? Dig Dis. 2012;30(1):64-9. doi: 10.1159/000335721. Epub 2012 May 3. Review. — View Citation

Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10. Review. — View Citation

Thabane M, Kottachchi DT, Marshall JK. Systematic review and meta-analysis: The incidence and prognosis of post-infectious irritable bowel syndrome. Aliment Pharmacol Ther. 2007 Aug 15;26(4):535-44. Review. — View Citation

Zanini B, Ricci C, Bandera F, Caselani F, Magni A, Laronga AM, Lanzini A; San Felice del Benaco Study Investigators. Incidence of post-infectious irritable bowel syndrome and functional intestinal disorders following a water-borne viral gastroenteritis outbreak. Am J Gastroenterol. 2012 Jun;107(6):891-9. doi: 10.1038/ajg.2012.102. Epub 2012 Apr 24. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The newly developed IBS The primary outcome was newly developed IBS. This was checked by telephone survey from 15th July 2013 to 30th September 2013. IBS was diagnosed by Rome III criteria. Survey was done from 15th July 2013 to 30th September 2013 No