Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry

NCT02633592 | Completed DMC

• 1 other identifier: KEK-ZH-Nr. 2014-0058
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more naturalistic / physiological upright, seated position on a commode provides a more valid assessment of anorectal function and simulated defecation than the same test performed in the standard, left lateral position

Conditions

Anismus; Incontinence

Keywords

High Resolution Anorectal Manometry; Magnetic Resonance Imaging; Balloon Expulsion; Position

Outcome Measures

Primary Outcomes (1)

• Recto-anal pressure gradient (RAPG)

  RAPG change in the LLP and sitting position (mmHg)

  1 hour

Secondary Outcomes (4)

• Presence of dyssynergia on HR-ARM

  1 hour

• Presence of dyssynergic defecation on MRI in healthy controls

  1 hour

• Agreement of MR findings in different body positions with HR-ARM findings

  1 hour

• Patient positional preference

  1 hour

Study Arms (2)

HRARM

ACTIVE COMPARATOR

Patients and healthy volunteers are subjected to position change ( LLP to SP) during pressure measurements with HR-ARM.

Other: HRARM

MRI Defecography

ACTIVE COMPARATOR

Patients and healthy volunteers are subjected to position change during MRI Defecography

Other: MRI Defecography

Interventions

HRARM OTHER

Patients and healthy volunteers are investigated in the seated and lying position during HRAM

HRARM

MRI Defecography OTHER

Patients and healthy volunteers are investigated in the supine and left lateral position in the MRI

Also known as: MRD

MRI Defecography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Male or female, age 18 - 75 years
• Females eligible to participate either if physiologically incapable of becoming pregnant or with a negative urine pregnancy test at screening
• HS: Absence of symptoms of constipation or incontinence
• Patients with fecal incontinence
• Passive or Urge Incontinence
• Wexner Score of 5-20 ("more than mild severity of incontinence")
• Patients with obstructive defecation
• Cleveland Clinic Constipation Scoring System: 10-30 ("more than mild severity of constipation)

You may not qualify if:

• Participation in any other clinical trial with investigational or approved drugs within the last month before the study
• Significant medical, surgical or psychiatric disease requiring on-going active management
• Previous gastrointestinal or gynaecological disease (exception: non symptomatic ovarian cysts, occasional reflux, appendectomy, hysterectomy, cholecystectomy)
• Regular use of opiates or other constipating agents
• Presence of fecal impaction on clinical per rectal exam
• Abnormal findings on proctoscopy / endoscopy (e.g. Inflammatory Bowel Disease, neoplasm, acute or chronic anal fissure, large haemorrhoids (grade 3-4) intussusception, prolapse or gross perineal descent (\>5cm) on straining
• Insufficient understanding of German language to comply with instructions
• Contraindication for MRI: Presence of non-MR-compatible metallic implants, devices or metallic foreign bodies

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department for Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

• Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. No abstract available.

  PMID: 23261065 BACKGROUND

• Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR. Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013 Feb;144(2):314-322.e2. doi: 10.1053/j.gastro.2012.10.049. Epub 2012 Nov 7.

  PMID: 23142135 BACKGROUND

• Noelting J, Ratuapli SK, Bharucha AE, Harvey DM, Ravi K, Zinsmeister AR. Normal values for high-resolution anorectal manometry in healthy women: effects of age and significance of rectoanal gradient. Am J Gastroenterol. 2012 Oct;107(10):1530-6. doi: 10.1038/ajg.2012.221. Epub 2012 Sep 18.

  PMID: 22986439 BACKGROUND

• Heinrich H, Fruehauf H, Sauter M, Steingotter A, Fried M, Schwizer W, Fox M. The effect of standard compared to enhanced instruction and verbal feedback on anorectal manometry measurements. Neurogastroenterol Motil. 2013 Mar;25(3):230-7, e163. doi: 10.1111/nmo.12038. Epub 2012 Nov 6.

  PMID: 23130678 BACKGROUND

Study Officials

• Henriette Heinrich

  Department for Gastroenterology and Hepatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 17, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

CH (1)