Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

NCT04101097 | Completed DMC

• 1 other identifier: KY20190903-3
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 5

Brief Summary

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy. This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.

Conditions

Colonoscopy; Bowel Preparation; Predictive Model

Keywords

factors;bowel preparation;colonoscopy

Outcome Measures

Primary Outcomes (1)

• Inadequate bowel preparation

  Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental\<2.

  1 hour

Secondary Outcomes (2)

• Adequacy of proximal bowel preparation

  1 hour

• Adequacy of distal bowel preparation

  1 hour

Study Arms (2)

training group

All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.

validation group

All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Using PEG for bowel preparation before colonoscopy

You may qualify if:

• Aged 18-80
• Using PEG for bowel preparation before colonoscopy

You may not qualify if:

• Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
• Colon resection
• Suspected bowel obstruction
• Hemodynamically unstable
• Lactating or pregnant women
• Unwilling to provided informed content

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• Shenzhen Hospital of Southern Medical University: collaborator
• Xiamen Humanity Hospital: collaborator
• Huaihe Hospital of Henan University: collaborator
• Shaanxi Second People's Hospital: collaborator

Study Sites (5)

Department of Gastroenterology, Hongai Hospital

Xiamen, Fujian, 361000, China

Location

Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 510000, China

Location

Department of Gastroenterology, Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

Location

Department of Gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, 710005, China

Location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related 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.

  PMID: 22239959 RESULT

• Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.

  PMID: 25600879 RESULT

• Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.

  PMID: 28282690 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 24, 2019
• Study Start: September 3, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (5)