An interventional study of Enhanced Frequency Ward Rounds with Standardized Intervention Package and Standard Frequency Ward Rounds in Colonoscopy, Bowel Preparation and Quality of Healthcare, sponsored by LanZhou University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by LanZhou University · Not applicable, Interventional, and Treatment
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.
Background and Rationale Adequate bowel preparation is essential for high-quality colonoscopy. The Boston Bowel Preparation Scale (BBPS) is a validated tool for assessing preparation quality, with scores ≥6 (and each segment ≥2) considered adequate. Studies report inadequate preparation rates of 20-30% in routine practice, leading to missed lesions, prolonged procedures, and increased costs.
Hospitalized patients face unique challenges for bowel preparation including comorbidities, cognitive impairment, medication complexity, and communication barriers. While outpatient preparation often relies on written instructions and telephone reminders, inpatients theoretically benefit from direct medical supervision. However, the optimal frequency and structure of ward rounds during bowel preparation remain undefined.
Current practice at our institution includes twice-daily resident ward rounds (morning and afternoon). We hypothesize that increasing ward round frequency to four times daily (adding midday and evening rounds) with a standardized intervention package will improve preparation quality by:
Design Features:
Timeline Structure:
Interventions
Control Group (Standard Care):
Intervention Group (Enhanced Ward Rounds):
Standardized intervention package at each round:
Standardized Elements (Both Groups): To isolate the effect of ward round frequency, all other aspects remain identical:
Primary Outcome:
Key Secondary Outcomes:
Subgroup Analyses (Pre-specified):
Sensitivity analyses will include per-protocol population (excluding participants with \<75% adherence to assigned ward round frequency), complete case analysis, and varying ICC assumptions. Subgroup effects will be assessed through treatment-by-subgroup interaction terms.
Safety Monitoring
The independent DSMB will conduct one interim analysis at 50% enrollment. Pre-specified stopping rules include:
LanZhou University is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
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.
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.
Time frame: Assessed during colonoscopy procedure (Day 0, examination day)
Boston Bowel Preparation Scale (BBPS) Total Score
BBPS total score as continuous variable (range 0-9), with higher scores indicating better preparation quality
Time frame: Assessed during colonoscopy procedure (Day 0)
Cecal Intubation Rate
Proportion of procedures achieving successful cecal intubation, confirmed by visualization of ileocecal valve and appendiceal orifice
Time frame: Assessed during colonoscopy procedure (Day 0)
Cecal Intubation Time
Time in minutes from scope insertion at anal verge to cecal intubation
Time frame: Assessed during colonoscopy procedure (Day 0)
Total Examination Duration
Total procedure time in minutes from scope insertion to scope withdrawal
Time frame: Assessed during colonoscopy procedure (Day 0)
Adenoma Detection Rate (ADR)
Proportion of patients in whom at least one adenoma is detected during colonoscopy, confirmed by pathology
Time frame: Assessed at time of pathology report (within 2 weeks post-procedure)
Preparation-Related Adverse Events
Composite outcome including: (1) Electrolyte abnormalities (potassium \<3.5 or \>5.5 mmol/L, sodium \<135 or \>145 mmol/L); (2) Aspiration events (vomiting with cough and pulmonary signs); (3) Severe nausea/vomiting requiring medication; (4) Dehydration requiring IV fluids
Time frame: From initiation of bowel preparation (Day -1) through colonoscopy completion (Day 0), approximately 24-36 hours
Procedure Rescheduling Rate
Proportion of patients requiring colonoscopy rescheduling or repeat bowel preparation due to inadequate initial preparation
Time frame: Within 7 days of originally scheduled procedure
Length of Hospital Stay
Total number of days from hospital admission to discharge
Time frame: From admission until discharge, expected average of 5-10 days
Total Hospitalization Costs
Total direct medical costs in Chinese Yuan (CNY) including room charges, medications, procedures, and laboratory tests, extracted from hospital information system
Time frame: From admission until discharge, expected average of 5-10 days
Patient Satisfaction Score
Patient-reported satisfaction with bowel preparation guidance assessed on 5-point Likert scale (1=very dissatisfied to 5=very satisfied)
Time frame: Within 24 hours after colonoscopy completion (Day 0)
Patient Preparation Tolerance
Patient-reported tolerance of preparation process on 5-point Likert scale (1=not difficult at all to 5=unbearable)
Time frame: Within 24 hours after colonoscopy completion (Day 0)
Night-time Nurse Call Frequency
Number of patient-initiated nurse calls during night hours (21:00-7:00), normalized per patient, extracted from nurse call system records
Time frame: Night before colonoscopy (Day -1 evening to Day 0 morning), approximately 10 hours
Nursing Workload Score
Nurse-reported workload assessment for each patient's bowel preparation period, assessed on 5-point Likert scale (1=same as routine patients to 5=significantly increased burden)
Time frame: Assessed at end of preparation period, within 24 hours after colonoscopy (Day 0)
Patient Knowledge Score
Patient understanding of preparation instructions assessed by 3-item questionnaire (timing of second PEG dose, permissible fluids, medication speed). Score range 0-3 with higher scores indicating better understanding.
Time frame: Evening before colonoscopy (Day -1, approximately 18:00-22:00)
Plan to share: No — Individual participant data will not be shared publicly due to institutional privacy policies and Chinese regulations on patient data protection. Aggregate results will be published in peer-reviewed journals and presented at scientific conferences. Researchers interested in collaboration or data access may contact the principal investigator to discuss potential data sharing arrangements under appropriate data use agreements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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