Trial Outcomes & Findings for Studies in Patients With Low Anterior Resection Syndrome (LARS) (NCT NCT03885999)

NCT ID: NCT03885999

Last Updated: 2022-01-19

Results Overview

The expected outcome is that the device will perform as shown in the previous human experiments (n\>60) where no adverse effects have been recorded.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: baseline and following intervention, approximately 30 seconds
• Results posted on: 2022-01-19

Participant Flow

This study was conducted at at Prince of Wales Hospital in Hong Kong from 29 May 2019 to 9 December 2019. The protocol was approved by the Ethics Review Committees of the involved hospital (CRE-2018.640). Written informed consent was obtained from each subject prior to commencement of the study.

Participant milestones

Measure	Fecobionics Studies Fecobionics: Fecobionics is a new device for studying defecation
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Fecobionics Studies Fecobionics: Fecobionics is a new device for studying defecation
Overall Study Adverse Event	1

Baseline Characteristics

Studies in Patients With Low Anterior Resection Syndrome (LARS)

Baseline characteristics by cohort

Measure	Fecobionics Studies n=11 Participants Fecobionics: Fecobionics is a new device for studying defecation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Hong Kong	11 Participants n=5 Participants
LARS score	39 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: baseline and following intervention, approximately 30 seconds

Population: 11 LARS patients

The expected outcome is that the device will perform as shown in the previous human experiments (n>60) where no adverse effects have been recorded.

Outcome measures

Measure	Fecobionics Studies n=11 Participants Fecobionics: Fecobionics is a new device for studying defecation
Change of Anorectal Pressure Assessed With the Fecobionics Device	9.8 cmH2O Standard Error 2.1

Adverse Events

Fecobionics Studies

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fecobionics Studies n=12 participants at risk Fecobionics: Fecobionics is a new device for studying defecation
Gastrointestinal disorders Perforation	8.3% 1/12 • 9 months Same definitions as the clinicaltrials.gov.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kaori Futaba

The Chinese University of Hong Kong, Department of Surgery, Prince of Wales Hospital

Phone: 0085264630121

Email: kfutaba@surgery.cuhk.edu.hk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place