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Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality 498 Randomized Novel Treatment

Not yet recruiting
Clinical Trial NCT07501975 is an interventional study for Colonoscopy and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 498 participants. Led by The First Affiliated Hospital of Zhengzhou University, this study is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
In recent years, with the continuous advancement of digestive endoscopy techniques, how to improve the adenoma detection rate (ADR) by optimizing endoscopic procedural details has become a research hotspot. Colonic spasm can lead to narrowing of the intestinal lumen, deepening of mucosal folds, and limited field of view, thereby affecting lesion exposure and reducing examination quality. Although traditional intraven...Show More
Official Title

Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality: A Randomized Controlled Trial Evaluating Efficacy and Safety

Conditions
Colonoscopy
Other Study IDs
  • 2026-KY-0395-001
NCT ID Number
NCT07501975
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
498
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIrrigation solution group
Endoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension). Preparation method: The solution was prepared using normal saline as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to obtain a 0.1% menthol solution. After complete dissoluti...Show More
Endoscopic irrigation was performed using a novel irrigation solution
Endoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension).
Placebo Comparatorplacebo group
Irrigation was performed endoscopically using normal saline.
Irrigation was performed endoscopically using normal saline.
Irrigation was performed endoscopically using normal saline.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adenoma detection rate (ADR).
ADR = (number of patients with at least one adenomatous polyp detected / total number of patients in the group) × 100%. Pathological diagnosis was used as the gold standard.
Day 0
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of intestinal spasm
The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group. Intestinal spasm scoring criteria: Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter. Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter. Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized. The maximum diameter is defined as the diameter of the intestinal lumen when fully distended.
Day 0
Spasm inhibition rate
The percentage of patients whose lumen opening exceeded two-thirds of the maximum diameter within 30 seconds after water injection irrigation, relative to the total number of patients in the group.
Day 0
Polyp detection rate (PDR)
PDR = (number of patients with at least one polyp detected / total number of patients in the group) × 100%.
Day 0
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Age between 18 and 75 years, regardless of gender;
  2. Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
  3. Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
  4. Voluntarily signed informed consent and able to cooperate with completing study-related assessments.

  1. Allergy to menthol, cyclodextrin, or related substances;
  2. History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
  3. Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
  4. Pregnant or lactating women;
  5. Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
  6. Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
  7. History of contraindications to colonoscopy or serious adverse reactions during previous procedures.
The First Affiliated Hospital of Zhengzhou University logoThe First Affiliated Hospital of Zhengzhou University
Study Responsible Party
Jianning Yao, Principal Investigator, Chief Physician, The First Affiliated Hospital of Zhengzhou University
Study Central Contact
Contact: Jianning Yao, 13733183434, [email protected]
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