The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

NCT04434625 | Completed DMC

• 1 other identifier: KY20200614-3
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 5

Brief Summary

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation. The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

Conditions

Colonoscopy; Bowel Preparation; Predictive Model

Keywords

factors; bowel preparation; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation

  Defined by each segmental BBPS≥2

  6 months

Secondary Outcomes (2)

• Adenoma detection rate

  6 months

• Overall complication related to bowel preparation

  6 months

Study Arms (2)

control group

NO INTERVENTION

Colonoscopy was performed in the control group directly.

model-based interference group

EXPERIMENTAL

Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score\<3 in IM group colonoscopy directly.

Drug: Polyethylene glycol

Interventions

Polyethylene glycol DRUG

Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score\<3 in IM group and those in the control group underwent colonoscopy directly

model-based interference group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18\~75 years
• Patients undergoing morning colonoscopy

You may not qualify if:

• colon resection;
• suspected bowel obstruction;
• moderate or severe complications related to drinking the 1st or 2rd dose of PEG
• hemodynamically unstable;
• lactating or pregnant women;
• no need to reach the ileocecal segment
• unwilling to provided informed content.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

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 (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Chen L, Kang X, Ren G, Luo H, Zhang L, Wang L, Zhao J, Zhang R, Zhang X, Zhao L, Pan Y. Individualized intervention based on a preparation-related prediction model improves adequacy of bowel preparation: A prospective, multi-center, randomized, controlled study. Dig Liver Dis. 2024 Mar;56(3):436-443. doi: 10.1016/j.dld.2023.09.001. Epub 2023 Sep 19.

  PMID: 37735023 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Yanglin Pan, M.D

  Air Force Military Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 17, 2020
• Study Start: June 14, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CN (5)