Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664543
Status:
TERMINATED
Last Update Posted:
2021-01-26
First Post:
2020-12-06
Brief Title:
Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy
Sponsor:
Parc Taulí Hospital Universitari
Organization:
Parc Taulí Hospital Universitari
Study Overview
Official Title:
Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy CriLi Study a Pilot Trial
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Organization and logistic problems due to COVID19 pandemy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CriLi
Brief Summary:
One tricky aspect of the recommendations for colonoscopy prep is diet This has a significant impact on the experience of the patient or participant in the screening program and on the other hand low adherence has been found in some studies despite a potential Hawthorne effect It is noteworthy that despite its impact on patient experience it is an area for which little evidence is available which is why the guidelines give low-quality recommendations and there is probably considerable variability in clinical practice
In the early days of colonoscopy a liquid diet for 48 hours was mainly recommended although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet Later the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet managing to increase tolerance and the quality of the preparation A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published
Although there is solid evidence in favor of a low-residue diet versus a liquid diet the investigators do not have evidence on how many days of a low-residue diet should be recommended and this is reflected in the ESGE European Society of Gastrointestinal Endoscopy and ASGE American Society of Gastrointestinal Endoscopy guidelines A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published There were no statistically significant differences in the rate of adequate preparations 827 vs 856 OR 12 95 IC 072 to 215 However this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed In relation to this our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis with 421 participants the non-inferiority of 1 day of diet is fulfilled rate of poor preparation in 1 day 095 vs 474 in 3 days d 5 difference -378 IC -688 to -112 38
It is likely taking into account the available evidence and its evolution that diet plays a secondary role in preparation Although no studies designed to directly assess this have been conducted the research group has indirect data
Walter et al under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep 39 They established a non-inferiority margin of -135 Their results show a rate of good preparation Boston 5 in 6872 944 in a liquid diet compared to 6068 882 in a low-residue diet p 004 with a difference of -508 demonstrating non-inferiority of the low residue diet
In the early days of colonoscopy a liquid diet for 48 hours was mainly recommended although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet Later the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet managing to increase tolerance and the quality of the preparation A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published
Although there is solid evidence in favor of a low-residue diet versus a liquid diet the investigators do not have evidence on how many days of a low-residue diet should be recommended and this is reflected in the ESGE European Society of Gastrointestinal Endoscopy and ASGE American Society of Gastrointestinal Endoscopy guidelines A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published There were no statistically significant differences in the rate of adequate preparations 827 vs 856 OR 12 95 IC 072 to 215 However this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed In relation to this our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis with 421 participants the non-inferiority of 1 day of diet is fulfilled rate of poor preparation in 1 day 095 vs 474 in 3 days d 5 difference -378 IC -688 to -112 38
It is likely taking into account the available evidence and its evolution that diet plays a secondary role in preparation Although no studies designed to directly assess this have been conducted the research group has indirect data
Walter et al under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep 39 They established a non-inferiority margin of -135 Their results show a rate of good preparation Boston 5 in 6872 944 in a liquid diet compared to 6068 882 in a low-residue diet p 004 with a difference of -508 demonstrating non-inferiority of the low residue diet
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None