Trial Outcomes & Findings for Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse (NCT NCT02774798)

NCT ID: NCT02774798

Last Updated: 2020-03-30

Results Overview

The pressure (in cmH20) at which the anal canl just begins to open

• Recruitment status: COMPLETED
• Target enrollment: 31 participants
• Primary outcome timeframe: at specific time point of measurement up to 1 hour
• Results posted on: 2020-03-30

Participant Flow

Participant milestones

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) Patients grade of rectal prolapse depending on Oxford grading criteria
Overall Study STARTED	7	17	7
Overall Study COMPLETED	7	17	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Garde 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse	Total n=31 Participants Total of all reporting groups
Age, Continuous	53 years n=7 Participants	64 years n=17 Participants	68 years n=7 Participants	61 years n=31 Participants
Sex: Female, Male Female	7 Participants n=7 Participants	13 Participants n=17 Participants	6 Participants n=7 Participants	26 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=7 Participants	4 Participants n=17 Participants	1 Participants n=7 Participants	5 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	7 participants n=7 Participants	17 participants n=17 Participants	7 participants n=7 Participants	31 participants n=31 Participants

PRIMARY outcome

Timeframe: at specific time point of measurement up to 1 hour

The pressure (in cmH20) at which the anal canl just begins to open

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Opening Pressure	56.35 cmH20 Standard Deviation 16.64	39.01 cmH20 Standard Deviation 18.02	23.42 cmH20 Standard Deviation 14.52

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

in cmH20/mm2 - the resistance of the anal canal to stretch

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Opening Elastance	1.72 cmH20/mm2 Standard Deviation 7.82	1.19 cmH20/mm2 Standard Deviation 0.40	0.93 cmH20/mm2 Standard Deviation 0.34

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

The pressure (cmH20) at whihc the anal canal just closes

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Closing Pressure	33.31 cmH20 Standard Deviation 10.84	22.78 cmH20 Standard Deviation 12.53	13.58 cmH20 Standard Deviation 9.80

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

In cmH20/mm2 - the ability of the anal canal to close after a period of stretch

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Closing Elastance	1.52 cmH20/mm2 Standard Deviation 0.63	1.05 cmH20/mm2 Standard Deviation 0.46	0.85 cmH20/mm2 Standard Deviation 0.41

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

measured as "%" - the percentage energy dissipated during opening and closing of the anal canal at rest

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Hysteresis	37.54 percent Standard Deviation 6.32	39.05 percent Standard Deviation 7.32	40.57 percent Standard Deviation 11.16

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Squeeze Opening Pressure	81.21 cmH2O Standard Deviation 41.46	82.91 cmH2O Standard Deviation 43.57	52.51 cmH2O Standard Deviation 33.58

SECONDARY outcome

Timeframe: at specific time point of measurement up to 1 hour

the resistance of the anal canal to stretch during voluntary contraction

Outcome measures

Measure	Intra-rectal Intussusception (Oxford Groups 1 &2) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Intra-anal Intussusception (Oxford Grades 3 & 4) n=17 Participants Patients grade of rectal prolapse depending on Oxford grading criteria	Overt Rectal Prolapse (Oxford Grade 5) n=7 Participants Patients grade of rectal prolapse depending on Oxford grading criteria
Squeeze Opening Elastance	1.46 cmH20/mm2 Standard Deviation 0.31	1.08 cmH20/mm2 Standard Deviation 0.28	1.29 cmH20/mm2 Standard Deviation 0.49

Adverse Events

Intra-rectal Intussusception (Oxford Groups 1 &2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intra-anal Intussusception (Oxford Grades 3 & 4)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overt Rectal Prolapse (Oxford Garde 5)

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

Nick Heywood

University Hospital of South Manchester

Phone: +447739002473

Email: nheywood@doctors.org.uk

Results disclosure agreements

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