Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

NCT07361575 | Not Yet Recruiting

• 1 other identifier: POG
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer Prevention; Colorectal Cancer (Diagnosis); Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Boston Score

  A 9-point system, helps them see how clean a patient's large intestine is during a colonoscopy. This scale divides the large intestine into three parts: right, middle, and left. Each part can score from : BBPS = 0 (per segment) : unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared. BPPS=3 (per segment) : entire mucosa of the colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.

  1 day

Study Arms (2)

Patient with LRD prepared 24 hours before colonoscopy

EXPERIMENTAL

The LRD prepared is Colobox

Procedure: Colonoscopy; Other: Questionnaires; Other: Pre-colonoscopy diet by following a special preparation, Colobox.

Patients with not prepared LRD, 24 hours before colonoscopy

ACTIVE COMPARATOR

The LRD is only explained orally and in writing to the patient

Procedure: Colonoscopy; Other: Questionnaires; Other: Pre-colonoscopy diet according to the investigator's oral instructions

Interventions

Pre-colonoscopy diet according to the investigator's oral instructions OTHER

24 hours before the colonoscopy, The patients follow a special diet, either by themselves according to the investigator's oral instructions

Patients with not prepared LRD, 24 hours before colonoscopy

Pre-colonoscopy diet by following a special preparation, Colobox. OTHER

24 hours before the colonoscopy, The patients follow a special diet, by following a special preparation, Colobox.

Patient with LRD prepared 24 hours before colonoscopy

Colonoscopy PROCEDURE

Colonoscopy performed and Boston score evaluated

Patient with LRD prepared 24 hours before colonoscopy; Patients with not prepared LRD, 24 hours before colonoscopy

Questionnaires OTHER

LRD satisfaction questionnaire LRD compliance questionnaire

Patient with LRD prepared 24 hours before colonoscopy; Patients with not prepared LRD, 24 hours before colonoscopy

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Paris-Bercy: lead

Study Sites (1)

Clinique Paris Bercy

Charenton-le-Pont, 94220, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Interventions

Colonoscopy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Coralie DE CLERCK

CONTACT

0033143967823; c.declerck@clinique-bercy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 23, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)