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

NCT05485103 | Unknown

• 1 other identifier: ZS-3300
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

modified bowel preparation method; inflammatory bowel disease; risk factors; quality of bowel preparation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Tolerance score of participants after bowel preparation.

  After bowel preparation and before colonoscopy

• Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.

  Within 30 days after colonoscopy

• Number of Participants hospitalized because of aggravation of disease after colonoscopy.

  Within 30 days after colonoscopy

Study Arms (2)

Modified bowel preparation method group

EXPERIMENTAL

One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken

Drug: Polyethylene Glycols

Traditional bowel preparation method group

ACTIVE COMPARATOR

Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)

Drug: Polyethylene Glycols

Interventions

Polyethylene Glycols DRUG

Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Also known as: glycerin enema, asol

Modified bowel preparation method group; Traditional bowel preparation method group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Sixth Hospital

Beijing, Beijing Municipality, China

RECRUITING

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

The first Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The second Affiliated Hospital of Baotou Medical Colledge

Baotou, Neimenggu, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

RECRUITING

Beijing Rectum Hospital

Beijing, China

RECRUITING

Related Publications (15)

• 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.

  PMID: 35579796 BACKGROUND

• 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.

  PMID: 35689818 BACKGROUND

• 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.

  PMID: 34487155 BACKGROUND

• 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.

  PMID: 33661246 BACKGROUND

• 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.

  PMID: 34034275 BACKGROUND

• 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.

  PMID: 33994129 BACKGROUND

• 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.

  PMID: 32237946 BACKGROUND

• 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.

  PMID: 30339950 BACKGROUND

• 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.

  PMID: 30785181 BACKGROUND

• 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.

  PMID: 30254405 BACKGROUND

• 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.

  PMID: 30390208 BACKGROUND

• 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.

  PMID: 29019424 BACKGROUND

• 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.

  PMID: 26866392 BACKGROUND

• 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.

  PMID: 24975529 BACKGROUND

• 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.

  PMID: 23664621 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hui Xu, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Hui Xu, MD

CONTACT

+86-010-69151591; xuhui10799@pumch.cn

Hong Yang, MD

CONTACT

yangh@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)