Trial Outcomes & Findings for Comparative Study Between Two Fecal Management Systems (NCT NCT01411488)

Results Overview

anal erosion within 14 days after insertion of FMS

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

up to 14 days

Results posted on

2020-07-30

Participant Flow

An interim analysis was planned one 70+ patients completed data collection to determine futility vs continued recruitment, enrollment and data collection. The analysis presented represents the interim analysis as it was determines that we should stop further recruitment and enrollment based on study findings.

An interim analysis was completed; see recruitment details

Participant milestones

Participant milestones
Measure	Fecal Management System- Company 1 47 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions Note, not all patients were retained	Fecal Management System- Company 2 43 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions Note: not all patients were retained
Overall Study STARTED	41	38
Overall Study COMPLETED	41	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study Between Two Fecal Management Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fecal Management System- Company 1 n=41 Participants 41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions 55% male; 60% had history of hemorrhoids	Fecal Management System- Company 2 n=38 Participants 38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions 45% male; 39.1% had history of hemorrhoids	Total n=79 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 15.0 • n=5 Participants	64.7 years STANDARD_DEVIATION 12.3 • n=7 Participants	64.0 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 14 days

Population: Pearson's chi square test (categorical data) and Wilcoxon test (continuous measures). Logistic regression was used to assess primary endpoint by time the device was in use.

anal erosion within 14 days after insertion of FMS

Outcome measures

Outcome measures
Measure	Fecal Management System- Company 1 n=41 Participants 41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions	Fecal Management System- Company 2 n=38 Participants 38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS	5 Participants	5 Participants

Adverse Events

Fecal Management System- Company 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fecal Management System- Company 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fecal Management System- Company 1 n=41 participants at risk 41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions	Fecal Management System- Company 2 n=38 participants at risk 38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
Gastrointestinal disorders did not get to day 1 or could not tolerate	7.3% 3/41 • Number of events 3 • During data collection for each subject. No follow up data collection Since rectal tube insertion is usual care, patient adverse evens were not recorded, only adverse events related to rectal tube care specifically	5.3% 2/38 • Number of events 2 • During data collection for each subject. No follow up data collection Since rectal tube insertion is usual care, patient adverse evens were not recorded, only adverse events related to rectal tube care specifically

Additional Information

Nancy Albert

Cleveland Clinic

Phone: 216-444-7028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place