Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy

NCT07263867 | Not Yet Recruiting

• 1 other identifier: LDYYczf2025112301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate bowel preparation is critical for successful colonoscopy, yet inadequate preparation remains a significant clinical challenge, occurring in 20-30% of procedures. In hospitalized patients undergoing therapeutic colonoscopy, suboptimal preparation leads to increased costs, prolonged hospital stay, and potential procedure cancellation or rescheduling. Current standard care involves resident ward rounds twice daily. This cluster-randomized crossover trial aims to evaluate whether increasing the frequency of structured resident ward rounds from 2 to 4 times per day can improve bowel preparation quality in hospitalized patients scheduled for therapeutic colonoscopy. The enhanced ward round intervention includes standardized checklist review, medication verification, dietary compliance confirmation, adverse event screening, and timely intervention when needed. Three hospital wards will be randomly assigned to different sequences of intervention and control periods using a crossover design with washout periods. The primary outcome is adequate bowel preparation quality assessed by Boston Bowel Preparation Scale (BBPS ≥6 with each segment ≥2), evaluated by blinded endoscopists. Secondary outcomes include procedure quality metrics (cecal intubation rate, examination duration), safety endpoints (electrolyte disturbances, aspiration events), health economics measures (length of stay, total costs), and healthcare worker burden (nursing workload, night-time call frequency). Subgroup analyses will examine intervention effects across age groups, cognitive function levels, prior colonoscopy experience, and comorbidity burden to identify populations most likely to benefit from enhanced monitoring. This pragmatic trial addresses a clinically relevant question using a real-world implementation strategy designed to minimize workflow disruption. Results will inform evidence-based policies regarding optimal ward round frequency for colonoscopy preparation in hospital settings.

Conditions

Colonoscopy; Bowel Preparation; Quality of Healthcare

Keywords

Bowel preparation; Ward rounds; Colonoscopy quality; Cluster randomized trial; Boston Bowel Preparation Scale

Outcome Measures

Primary Outcomes (1)

• Adequate Bowel Preparation Rate

  Proportion of patients achieving adequate bowel preparation defined as Boston Bowel Preparation Scale (BBPS) total score ≥6 points AND each colonic segment score ≥2 points. BBPS is a validated 0-9 point scale (3 segments × 0-3 points each) assessing preparation quality during colonoscopy. Endoscopist records BBPS score for each segment (right colon, transverse colon, left colon) after cleansing maneuvers during colonoscopy. Adequate preparation requires both: (1) total score ≥6 and (2) no segment with score \<2. Endoscopists remain blinded to patient group assignment.

  Assessed during colonoscopy procedure (Day 0, examination day)

Secondary Outcomes (14)

• Boston Bowel Preparation Scale (BBPS) Total Score

  Assessed during colonoscopy procedure (Day 0)

• Cecal Intubation Rate

  Assessed during colonoscopy procedure (Day 0)

• Cecal Intubation Time

  Assessed during colonoscopy procedure (Day 0)

• Total Examination Duration

  Assessed during colonoscopy procedure (Day 0)

• Adenoma Detection Rate (ADR)

  Assessed at time of pathology report (within 2 weeks post-procedure)

Study Arms (2)

Enhanced Ward Rounds (Intervention)

EXPERIMENTAL

Residents conduct ward rounds 4 times daily (morning, midday, afternoon, evening) with each visit lasting ≥10 minutes. Standardized intervention package includes: (1) medication verification and adherence check, (2) dietary compliance review, (3) adverse event screening for electrolyte disturbances and aspiration risk, (4) clinical decision support with timely interventions, and (5) patient education assessment. Electronic check-in required at each visit with time-stamped checklist completion.

Behavioral: Enhanced Frequency Ward Rounds with Standardized Intervention Package

Standard Ward Rounds

ACTIVE COMPARATOR

Standard care with residents conducting ward rounds 2 times daily (morning and afternoon). Patients receive routine clinical assessment and verbal confirmation of bowel preparation instructions. All other aspects of care remain identical to intervention group including PEG preparation regimen, dietary protocol, patient education materials, and rescue protocols.

Behavioral: Standard Frequency Ward Rounds

Interventions

Standard Frequency Ward Rounds BEHAVIORAL

Standard care with resident physician ward rounds twice daily at morning (7:30-9:00) and afternoon (15:00-17:00). Routine clinical assessment and verbal confirmation of preparation protocol. Represents current practice standard.

Standard Ward Rounds

Enhanced Frequency Ward Rounds with Standardized Intervention Package BEHAVIORAL

Increase resident physician ward round frequency from 2 to 4 times per day (adding midday 12:00-13:00 and evening 21:00-22:00 rounds). Each ward round includes standardized checklist-based assessment covering medication adherence, dietary compliance, adverse events, and patient understanding. Duration ≥10 minutes per patient. Electronic documentation with time stamps ensures adherence monitoring.

Enhanced Ward Rounds (Intervention)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Hospitalized patients (inpatients)
• Scheduled for therapeutic colonoscopy (polypectomy, endoscopic mucosal resection \[EMR\], endoscopic submucosal dissection \[ESD\], or biopsy for diagnosis)
• Time from admission to scheduled colonoscopy ≥48 hours (allowing adequate preparation time)
• Patient or legal representative able to provide written informed consent
• Able to understand and follow bowel preparation instructions (with assistance from caregivers if needed)

You may not qualify if:

• Emergency gastrointestinal conditions: bowel obstruction, acute lower gastrointestinal bleeding requiring urgent intervention, suspected or confirmed perforation
• Emergency or same-day colonoscopy (scheduled \<24 hours after admission)
• History of total colectomy or current colostomy/ileostomy
• Severe cognitive impairment (Mini-Cog score 0-1 or MMSE \<18) without available caregiver
• Severe cardiopulmonary disease: New York Heart Association (NYHA) Class IV heart failure, chronic kidney disease (CKD) stage 4-5 (eGFR \<30 ml/min/1.73m²) unable to tolerate PEG-based preparation
• Known or suspected pregnancy, currently breastfeeding
• Previous severe allergic reaction to PEG or bowel preparation agents
• Current participation in another interventional clinical trial
• Unable to provide informed consent and no legal representative available
• Patient or legal representative declines participation

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Related Publications (5)

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 BACKGROUND

• Clark BT, Rustagi T, Laine L. What level of bowel prep quality requires early repeat colonoscopy: systematic review and meta-analysis of the impact of preparation quality on adenoma detection rate. Am J Gastroenterol. 2014 Nov;109(11):1714-23; quiz 1724. doi: 10.1038/ajg.2014.232. Epub 2014 Aug 19.

  PMID: 25135006 BACKGROUND

• Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.

  PMID: 25239068 BACKGROUND

• Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

  PMID: 31295746 BACKGROUND

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

  PMID: 19136102 BACKGROUND

Central Study Contacts

Qiangqiang Tian

CONTACT

86+15009460497; tianqq2023@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Endoscopists performing colonoscopy and assessing BBPS scores are blinded to patient group assignment. Due to the nature of the ward round intervention, participants and care providers cannot be blinded. Data analysts will remain blinded to group allocation until after primary analysis completion.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro

Model Details: Cluster-randomized crossover design. Three hospital wards will be randomly assigned to different sequences of control and intervention periods. Each ward crosses over between control (2 ward rounds/day) and intervention (4 ward rounds/day) conditions with 1-week washout periods between phases.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: March 28, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)