Clinical trial · Interventional
Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD. Few studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation. The aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Prevention | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| Pre-colonoscopy diet according to the investigator's oral instructions | Other | — | UNRESOLVED |
| Pre-colonoscopy diet by following a special preparation, Colobox. | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient with LRD prepared 24 hours before colonoscopy
- description
- The LRD prepared is Colobox
- interventionNames
- Procedure: Colonoscopy
- Other: Questionnaires
- Other: Pre-colonoscopy diet by following a special preparation, Colobox.
- type
- ACTIVE_COMPARATOR
- label
- Patients with not prepared LRD, 24 hours before colonoscopy
- description
- The LRD is only explained orally and in writing to the patient
- interventionNames
- Procedure: Colonoscopy
- Other: Questionnaires
- Other: Pre-colonoscopy diet according to the investigator's oral instructions
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient of one of the investigators for total colonoscopy (no prior colonic surgery); * Patient aged 18 years or older; * Patient classified as ASA 1, ASA 2, or ASA 3; * Not participating in any other current clinical trial; * Free, informed, and signed consent; * Patient affiliated with or a beneficiary of a social security scheme, according to Article L.1124-1 of the French Public Health Code; Exclusion Criteria: * Patient taking major psychotropic medications; * Patient with uncontrolled diabetes; * Patient with coagulation abnormalities preventing polypectomy: PT \<50%, Platelets \<50,000/mm³, current effective anticoagulation therapy (clopidogrel, prasugrel, or ticagrelor); * Patient referred for removal of a known polyp; * Chronic inflammatory bowel disease; * Known colonic stenosis; * Diverticulitis of less than 6 weeks duration; * Pregnant, parturient, or breastfeeding woman; * Patient deprived of liberty by administrative or judicial order, or under guardianship or limited legal protection; * Patient unable to understand the objectives and constraints of the study.
References
Publications (0)
Data not yet available