Davide Bellini1,2, Domenico De Santis1,2, Damiano Caruso1,2, Marco Rengo1,2, Riccardo Ferrari3, Tommaso Biondi1,2, Andrea Laghi4,5. 1. Department of Radiological Sciences, Oncology and Pathology, "SAPIENZA" University of Rome, Rome, Italy. 2. I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy. 3. Department of Emergency Radiology, San Camillo Forlanini Hospital, Rome, Italy. 4. Department of Radiological Sciences, Oncology and Pathology, "SAPIENZA" University of Rome, Rome, Italy. andrea.laghi@uniroma1.it. 5. I.C.O.T. Hospital, Via Franco Faggiana, 1668, 04100, Latina, Italy. andrea.laghi@uniroma1.it.
Abstract
OBJECTIVES: To investigate whether diet restriction affects quality of colon cleansing and patient tolerance during reduced bowel preparation for CT colonography (CTC). METHODS:Asymptomatic and symptomatic patients were enrolled in this pragmatic, single-centre, randomised trial. All patients were randomly assigned (1:1 ratio, blocks of ten) to receive a reduced bowel preparation and faecal tagging with (Diet-Restriction-Group [DR]) or without (No-Diet-Restriction-Group [NDR]) dietary restriction. Five readers performed a blinded subjective image analysis, by means of 4-point Likert-scales from 0 (highest score) to 3 (worst score). Endpoints were the quality of large bowel cleansing and tolerance to the assigned bowel preparation regimen. The trial is registered at ClinicalTrial.gov (URomLSDBAL1). RESULTS:Ninety-five patients were randomly allocated to treatments (48 in NDR-group, 47 in DR-group). Both groups resulted in optimal colon cleansing. The mean residual stool (0.22, 95%CI 0.00-0.44) and fluid burden (0.39, 95%CI 0.25-0.53) scores for patients in DR-group were similar to those in patients in NDR-group (0.25, 95%CI 0.03-0.47 [p = 0.82] and 0.49, 95%CI 0.30-0.67 [p = 0.38], respectively). Tolerance was significantly better in NDR-group. CONCLUSION: A reduced bowel preparation in association with faecal tagging and without any dietary restriction demonstrated optimal colon cleansing effectiveness for CTC, providing better patient compliance compared with dietary restriction. KEY POINTS: • Dietary restriction in reduced bowel preparation regimen can be avoided. • The quality of colon cleansing is not affected by dietary restriction. • The quality of faecal tagging is not affected by dietary restriction. • Avoidance of dietary restriction improves patients' tolerance for CTC.
RCT Entities:
OBJECTIVES: To investigate whether diet restriction affects quality of colon cleansing and patient tolerance during reduced bowel preparation for CT colonography (CTC). METHODS: Asymptomatic and symptomatic patients were enrolled in this pragmatic, single-centre, randomised trial. All patients were randomly assigned (1:1 ratio, blocks of ten) to receive a reduced bowel preparation and faecal tagging with (Diet-Restriction-Group [DR]) or without (No-Diet-Restriction-Group [NDR]) dietary restriction. Five readers performed a blinded subjective image analysis, by means of 4-point Likert-scales from 0 (highest score) to 3 (worst score). Endpoints were the quality of large bowel cleansing and tolerance to the assigned bowel preparation regimen. The trial is registered at ClinicalTrial.gov (URomLSDBAL1). RESULTS: Ninety-five patients were randomly allocated to treatments (48 in NDR-group, 47 in DR-group). Both groups resulted in optimal colon cleansing. The mean residual stool (0.22, 95%CI 0.00-0.44) and fluid burden (0.39, 95%CI 0.25-0.53) scores for patients in DR-group were similar to those in patients in NDR-group (0.25, 95%CI 0.03-0.47 [p = 0.82] and 0.49, 95%CI 0.30-0.67 [p = 0.38], respectively). Tolerance was significantly better in NDR-group. CONCLUSION: A reduced bowel preparation in association with faecal tagging and without any dietary restriction demonstrated optimal colon cleansing effectiveness for CTC, providing better patient compliance compared with dietary restriction. KEY POINTS: • Dietary restriction in reduced bowel preparation regimen can be avoided. • The quality of colon cleansing is not affected by dietary restriction. • The quality of faecal tagging is not affected by dietary restriction. • Avoidance of dietary restriction improves patients' tolerance for CTC.
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