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

Colonoscopy Clinical Trial

Official title:

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434625
• Other study ID #: KY20200614-3
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: March 1, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18~75 years

• Patients undergoing morning colonoscopy

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Predictive Model

Intervention

Drug:
• Polyethylene glycol
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

Locations

Country	Name	City	State
China	Department of Gastroenterology, Huaihe Hospital of Henan University	Kaifeng	Henan
China	Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong
China	Department of Gastroenterology, Shaanxi Second People's Hospital	Xi'an	Shaanxi
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Department of Gastroenterology, Hongai Hospital	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Dik VK, Moons LM, Hüyük M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fèvre DM, Stouten M, van der Galiën 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. — View Citation

Gimeno-García AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Pérez CD, Nicolás-Pérez D, Alarcon-Fernández O, Jiménez 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate bowel preparation	Defined by each segmental BBPS=2	6 months
Secondary	Adenoma detection rate	The proportion of participants with at least one adenoma in each group	6 months
Secondary	Overall complication related to bowel preparation		6 months