Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation

Constipation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842411
• Other study ID #: 20160616-5
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2016
• Last updated: October 29, 2016
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Fourth Military Medical University
• Contact: Yanglin Pan, MD
• Phone: +862984771536
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90

• Patients undergoing colonoscopy;

• Patients meeting the criteria of chronic constipation of Rome ?;

Exclusion Criteria:

• history of colorectal surgery;

• known of suspected colonic stricture or obstructing tumour;

• ulcerative colitis;

• Crohn's disease;

• irritable bowel syndrome;

• toxic colitis or megacolon;

• known or suspected bowel obstruction or perforation;

• pregnancy or lactation;

• unable to give informed consent;

• haemodynamically unstable.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Locations

Country	Name	City	State
China	Chinese PLA 451 Hospital	Xi'an	Shaanxi
China	Tangdu Hospital	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10. — View Citation

Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. — View Citation

Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequate rate of bowel preparation =6 with each segment =2	The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.	6 months	Yes
Secondary	polyp detection rate		6 months	Yes
Secondary	insertion time		6 months	Yes
Secondary	withdrawal time		6 months	Yes