Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles.

Rectal intussusception occurs when the rectal wall telescopes into itself distally and is termed prolapse when it protrudes through the anal canal. Not all patients will require surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal incontinence. Currently, the Oxford grading system through radiological testing is used for classifying severity of rectal intussusception and prolapse; however this does not give us sufficient information about the anal sphincter muscles.

The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. Thus far, it has not been studied in patients with rectal intussusception and it is hoped that AAR parameters may provide an indication of when rectal intussusception becomes overt rectal prolapse. This can inform the clinician to guide further management of a group of patients with a condition that can have significant impact on quality of life.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Normal Values in Ano-rectal 3D High Resolution Manometry

NCT01710579

Anorectal Disorder Fecal Incontinence Constipation

COMPLETED NA

Does Body Position Influence Pressure Recording by High-resolution Manometry ?

NCT01946334

Anal Incontinence or Constipation

COMPLETED NA

Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy

NCT04350632

Obstetric Anal Sphincter Injury

UNKNOWN NA

3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

NCT04817150

Rectocele; Female Rectocele and Incomplete Uterine Prolapse Rectocele and Complete Uterovaginal Prolapse +1 more

UNKNOWN NA

Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.

NCT03743701

Anal Fistula

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This an observational study based on not intervention. Patients are grouped depending on grade of prolapse, and all undergo the routine AAR investigation. Patients are grouped solely on differences in pathology already present and not on any intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rectal Intussusception and Prolapse

AAR measurements will be taken from patients with suspected intra-rectal intussusception or rectal prolapse. Subgroup analysis will be performed after grading of rectal prolapse according to the Oxford Grading system. The subgroups will be:

1. Oxford Grades 1 \& 2 - intra-rectal intussusception
2. Oxford Grades 3 \& 4 - intra-anal intussusception
3. Oxford grade 5 - Overt Rectal Prolapse

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults over 18 years old
* Have capacity to consent to the study
* Patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse

Exclusion Criteria

* Minors under the age of 18 years old
* Patients who lack capacity to consent
* Patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No