NCT02842411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

June 25, 2016

Last Update Submit

October 29, 2016

Conditions

Constipation

Keywords

bowel preparationchronic constipationrisk factor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • polyp detection rate

    6 months

  • insertion time

    6 months

  • withdrawal time

    6 months

Study Arms (1)

chronic constipation

patients with chronic constipation based on Rome Ⅳ

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients \>=18 years old undergoing colonoscopy

You may qualify if:

  • Patients undergoing colonoscopy;
  • Patients meeting the criteria of chronic constipation of Rome Ⅳ;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

RECRUITING

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Chinese PLA 451 Hospital

Xi'an, Shaanxi, 710054, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11419832BACKGROUND

  • 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.

    PMID: 22239959BACKGROUND

  • 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.

    PMID: 21606976RESULT

  • 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.

    PMID: 31605278DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yanglin Pan, MD

    Xijing Hospital of Digestive Disease

    PRINCIPAL INVESTIGATOR

  • Mingxin Zhang, MD

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

  • Shiyang Ma, MD

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Yujie Jing, MD

    Chinese PLA 451 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanglin Pan, MD

CONTACT

+862984771536yanglinpan@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

June 25, 2016

First Posted

July 22, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-08

Locations

CN(4)