Clinical trial NCT02842411: Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Keywords: bowel preparation
chronic constipation
risk factor
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients \>=18 years old undergoing colonoscopy

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 18-90
* Patients undergoing colonoscopy;
* Patients meeting the criteria of chronic constipation of Rome Ⅳ;

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.

Primary outcomes:
measure: adequate rate of bowel preparation ≥6 with each segment ≥2
timeFrame: 6 months
Secondary outcomes:
measure: polyp detection rate
timeFrame: 6 months
measure: insertion time
timeFrame: 6 months
measure: withdrawal time
timeFrame: 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Chinese PLA 451 Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Disease
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tang-Du Hospital
name: Mingxin Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shiyang Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA 451 Hospital
name: Yujie Jing, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1572-0241.2001.03874.x.
citation: 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.
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.
citation: Guo X, Shi X, Kang X, Luo H, Wang X, Jia H, Tao Q, Wang J, Zhang M, Wang J, Lu X, Ma S, Lin T, Jing Y, Pan Y, Guo X, Fan D. Risk Factors Associated with Inadequate Bowel Preparation in Patients with Functional Constipation. Dig Dis Sci. 2020 Apr;65(4):1082-1091. doi: 10.1007/s10620-019-05847-5. Epub 2019 Oct 12.