Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586634
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2020-09-30
Brief Title:
Randomized Clinical Trial on Transanal Irrigation
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care
The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter
Design of the investigation This is a randomised open-label parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS LARS score 30 Each subject will be enrolled for a study duration of 12 weeks Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy
The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management This is defined as Supportive therapy according to the individual treatment protocols available at each participating site
Primary endpoint and secondary endpoints
Primary endpoint
LARS score obtained from the LARS score questionnaire
Secondary endpoints
Number of subjects with Major LARS
FIQL Score - scale 1 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 2 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 3 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 4 Modified American Society for Colorectal Surgeons Questionnaire
EQ-5D-5L - utility score
EQ-5D-5L - VAS score scale 0-10 cm
Satisfaction with treatment scale 0-10 cm
Number of adverse events All endpoints are measured per subject at study completion
The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter
Design of the investigation This is a randomised open-label parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS LARS score 30 Each subject will be enrolled for a study duration of 12 weeks Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy
The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management This is defined as Supportive therapy according to the individual treatment protocols available at each participating site
Primary endpoint and secondary endpoints
Primary endpoint
LARS score obtained from the LARS score questionnaire
Secondary endpoints
Number of subjects with Major LARS
FIQL Score - scale 1 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 2 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 3 Modified American Society for Colorectal Surgeons Questionnaire
FIQL Score - scale 4 Modified American Society for Colorectal Surgeons Questionnaire
EQ-5D-5L - utility score
EQ-5D-5L - VAS score scale 0-10 cm
Satisfaction with treatment scale 0-10 cm
Number of adverse events All endpoints are measured per subject at study completion
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