A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485103
• Other study ID #: ZS-3300
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: Hui Xu, MD
• Phone: +86-010-69151591
• Email: xuhui10799[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.

• Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.

Exclusion Criteria:

• The diagnosis is not definite.

• Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.

• Patients after colon surgery.

• Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.

• Patients can not cooperate with the use of polyethylene glycol or glycerin enema.

• Patients or family members cannot understand the conditions and objectives of this study.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Polyethylene Glycols
Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Locations

Country	Name	City	State
China	The second Affiliated Hospital of Baotou Medical Colledge	Baotou	Neimenggu
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Rectum Hospital	Beijing
China	Beijing Sixth Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Heilongjiang Provincial Hospital	Ha'erbin	Heilongjiang
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The first Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (15)

Bessissow T, Van Keerberghen CA, Van Oudenhove L, Ferrante M, Vermeire S, Rutgeerts P, Van Assche G. Anxiety is associated with impaired tolerance of colonoscopy preparation in inflammatory bowel disease and controls. J Crohns Colitis. 2013 Dec;7(11):e580-7. doi: 10.1016/j.crohns.2013.04.011. Epub 2013 May 9. — View Citation

Bezzio C, Andreozzi P, Casini V, Manes G, Saibeni S. Endoscopy for patients affected by inflammatory bowel disease: bowel preparation and sedation. Expert Rev Gastroenterol Hepatol. 2018 Feb;12(2):119-124. doi: 10.1080/17474124.2017.1390430. Epub 2017 Oct 17. — View Citation

Briot C, Faure P, Parmentier AL, Nachury M, Trang C, Viennot S, Altwegg R, Bulois P, Thomassin L, Serrero M, Ah-Soune P, Gilletta C, Plastaras L, Simon M, Dray X, Caillo L, Del Tedesco E, Abitbol V, Zallot C, Degand T, Rossi V, Bonnaud G, Colin D, Morel B, Winkfield B, Danset JB, Filippi J, Amiot A, Attar A, Levy J, Peyrin-Biroulet L, Vuitton L; CLEAN Study Group. Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study. J Crohns Colitis. 2019 Sep 19;13(9):1121-1130. doi: 10.1093/ecco-jcc/jjz040. — View Citation

Kim KO, Kim EY, Lee YJ, Lee HS, Kim ES, Chung YJ, Jang BI, Kim SK, Yang CH. Efficacy, safety and tolerability of oral sulphate tablet for bowel preparation in patients with inflammatory bowel disease: A multicentre randomized controlled study. J Crohns Colitis. 2022 Nov 23;16(11):1706-1713. doi: 10.1093/ecco-jcc/jjac080. — View Citation

Maida M, Morreale GC, Sferrazza S, Sinagra E, Scalisi G, Vitello A, Vettori G, Rossi F, Catarella D, Di Bartolo CE, Schillaci D, Raimondo D, Camilleri S, Orlando A, Macaluso FS. Effectiveness and safety of 1L PEG-ASC preparation for colonoscopy in patients with inflammatory bowel diseases. Dig Liver Dis. 2021 Sep;53(9):1171-1177. doi: 10.1016/j.dld.2021.04.006. Epub 2021 May 12. — View Citation

Martel M, Menard C, Restellini S, Kherad O, Almadi M, Bouchard M, Barkun AN. Which Patient-Related Factors Determine Optimal Bowel Preparation? Curr Treat Options Gastroenterol. 2018 Dec;16(4):406-416. doi: 10.1007/s11938-018-0208-9. — View Citation

Megna B, Weiss J, Ley D, Saha S, Pfau P, Grimes I, Li Z, Caldera F. Clear liquid diet before bowel preparation predicts successful chromoendoscopy in patients with inflammatory bowel disease. Gastrointest Endosc. 2019 Feb;89(2):373-379.e2. doi: 10.1016/j.gie.2018.09.039. Epub 2018 Oct 16. — View Citation

Negreanu L, Voiosu T, State M, Mateescu RB. Quality of colonoscopy preparation in patients with inflammatory bowel disease: retrospective analysis of 348 colonoscopies. J Int Med Res. 2020 Apr;48(4):300060520903654. doi: 10.1177/0300060520903654. — View Citation

Neri B, Scarozza P, Giannarelli D, Sena G, Mossa M, Lolli E, Calabrese E, Biancone L, Grasso E, Di Iorio L, Troncone E, Monteleone G, Paoluzi OA, Del Vecchio Blanco G. Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2021 Jul 1;33(7):977-982. doi: 10.1097/MEG.0000000000002167. — View Citation

Nett A, Velayos F, McQuaid K. Quality bowel preparation for surveillance colonoscopy in patients with inflammatory bowel disease is a must. Gastrointest Endosc Clin N Am. 2014 Jul;24(3):379-92. doi: 10.1016/j.giec.2014.03.004. Epub 2014 May 6. — View Citation

Reddy P, Mencin A, Lebwohl B. Risk Factors for Suboptimal Bowel Preparation for Colonoscopy in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2021 Jul 1;73(1):e1-e6. doi: 10.1097/MPG.0000000000003114. — View Citation

Shobar RM, Velineni S, Keshavarzian A, Swanson G, DeMeo MT, Melson JE, Losurdo J, Engen PA, Sun Y, Koenig L, Mutlu EA. The Effects of Bowel Preparation on Microbiota-Related Metrics Differ in Health and in Inflammatory Bowel Disease and for the Mucosal and Luminal Microbiota Compartments. Clin Transl Gastroenterol. 2016 Feb 11;7(2):e143. doi: 10.1038/ctg.2015.54. — View Citation

Spiceland CM, Lodhia N. Endoscopy in inflammatory bowel disease: Role in diagnosis, management, and treatment. World J Gastroenterol. 2018 Sep 21;24(35):4014-4020. doi: 10.3748/wjg.v24.i35.4014. — View Citation

Sultan K, Trindade AJ. Concise Commentary: Is Splitting the Difference? Identifying Risk Factors Associated with Suboptimal Bowel Preparation for Colonoscopy Among IBD Patients. Dig Dis Sci. 2022 Oct;67(10):4602-4603. doi: 10.1007/s10620-022-07533-5. Epub 2022 May 17. No abstract available. — View Citation

Wijnands AM, Te Groen M, Peters Y, Kaptein AA, Oldenburg B, Hoentjen F, Lutgens MWMD. Patients Prioritize a Low-volume Bowel Preparation in Colitis-associated Colorectal Cancer Surveillance: A Discrete Choice Experiment. Inflamm Bowel Dis. 2022 Jul 1;28(7):1053-1060. doi: 10.1093/ibd/izab221. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of bowel preparation evaluated by endoscopists during colonoscopy.	The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).	During colonoscopy examination
Primary	Number of Participants with increased Disease activity after colonoscopy.	Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.	Within 7 days after colonoscopy
Secondary	Tolerance score of participants after bowel preparation.	Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).	After bowel preparation and before colonoscopy
Secondary	Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.	Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.	Within 30 days after colonoscopy
Secondary	Number of Participants hospitalized because of aggravation of disease after colonoscopy.	Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.	Within 30 days after colonoscopy