Trial Outcomes & Findings for Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter (NCT NCT02782364)

NCT ID: NCT02782364

Last Updated: 2021-01-22

Results Overview

Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open

• Recruitment status: COMPLETED
• Target enrollment: 36 participants
• Primary outcome timeframe: 10 minutes
• Results posted on: 2021-01-22

Participant Flow

Patients attending clinic for routine evaluation of faecal incontinence were approached to particpate in this study

Participant milestones

Measure	Stepwise First, Then Fast-fill Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo stepwise measurement first and another half of the patients will have stepwise measurement first. Patients in this arm underwent stepwise, followed by a two minute rest, then fast fill, followed by a two minute rest, and then by manometry	Fast-fill First, Then Stepwise Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo fast-fill measurement first and another half of the patients will have step-wise measurement first. Patient min this arm underwent fast fill, followed by a two minute rest, then step wise, followed by a two minute rest, and then by manometry
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis of a total of 32 patients was performed. Measurement data from four patients was not able to be accurately interpreted

Baseline characteristics by cohort

Measure	Faecal Incontinence n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 16 patients will undergo fast-fill measurement first and another 16 patients will have step-wise measurement first
Age, Categorical <=18 years	0 Participants n=32 Participants • Analysis of a total of 32 patients was performed. Measurement data from four patients was not able to be accurately interpreted
Age, Categorical Between 18 and 65 years	23 Participants n=32 Participants • Analysis of a total of 32 patients was performed. Measurement data from four patients was not able to be accurately interpreted
Age, Categorical >=65 years	9 Participants n=32 Participants • Analysis of a total of 32 patients was performed. Measurement data from four patients was not able to be accurately interpreted
Age, Continuous	60 years n=32 Participants
Sex: Female, Male Female	26 Participants n=32 Participants • Measurement data from four patients was not able to be accurately interpreted
Sex: Female, Male Male	6 Participants n=32 Participants • Measurement data from four patients was not able to be accurately interpreted
Region of Enrollment United Kingdom	32 participants n=32 Participants • Measurement data from four patients was not able to be accurately interpreted

PRIMARY outcome

Timeframe: 10 minutes

Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Opening Pressure	35.13 cmH2O Interval 9.87 to 102.7	37.5 cmH2O Interval 13.84 to 117.7

PRIMARY outcome

Timeframe: 10 minutes

Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Opening Elastance	0.84 cm H2O/mm2 Interval 0.7 to 1.04	1.31 cm H2O/mm2 Interval 0.7 to 2.41

PRIMARY outcome

Timeframe: 10 minutes

Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Closing Pressure	27.22 cmH2O Interval 7.97 to 97.44	22.7 cmH2O Interval 5.35 to 82.35

PRIMARY outcome

Timeframe: 10 minutes

Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Closing Elastance	0.88 cm H2O/mm2 Interval 0.41 to 1.57	1.11 cm H2O/mm2 Interval 0.58 to 2.07

PRIMARY outcome

Timeframe: 10 minutes

Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Hysteresis	19.04 percentage Interval 1.62 to 53.01	35.75 percentage Interval 20.33 to 52.57

PRIMARY outcome

Timeframe: 10 minutes

Squeeze opening pressure (SqOp - cm H20) - the pressure at which the anal canal just starts to open whilst the patient is voluntarily trying to keep the anal canal closed

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Squeeze Opening Pressure	59.47 cmH2O Interval 9.15 to 200.0	69.87 cmH2O Interval 19.65 to 156.0

PRIMARY outcome

Timeframe: 10 minutes

Squeeze opening elastance (Sq)e - cm H20/mm2) - the resistance of the anal canal to stretch whilst the patient is voluntarily trying to keep the anal canal closed

Outcome measures

Measure	Stepwise n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill n=32 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Squeeze Opening Elastance	1.06 cmH20/mm2 Interval 0.44 to 2.6	1.27 cmH20/mm2 Interval 0.87 to 2.2

SECONDARY outcome

Timeframe: 10 minutes

Population: 29 patient analysed due to equipment issues performing for other 3 patients. It was pre-specified to combine data collected from the manometry regardless of the sequence of administration of techniques for AAR measurements as previous study had previously shown that the order of data collection did not impact on the measurements obtained

anal manometry measured in cmH20

Outcome measures

Measure	Stepwise n=29 Participants Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.	Fast-fill Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
Manometry - Resting Pressure	45 cmH20 Interval 15.0 to 151.0	—

Adverse Events

Stepwise First, Then Fast-fill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fast-fill First, Then Stepwise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Telford

University Hospital of South Manchester

Phone: 01612916654

Email: karen.telford@uhsm.nhs.uk

Results disclosure agreements

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