Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers

NCT01456442 | Completed Phase 4 DMC

• 1 other identifier: KEK-ZH-Nr. 2010-0330
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with a short protocol barostat versus conventional procedures (i.e. standard barostat protocol and high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the development of fecal incontinence and symptoms of obstructive defecation. In this study volunteers will be examined - after explanation, physical examination and verification of in- and exclusion criteria - by anorectal barostat with short and standard protocol as well as by proctoscopy and endoanal ultrasound.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers

  during hospital stay, estmated 0.5 days

Secondary Outcomes (1)

• anorectal perception thresholds in % in relation to rectal capacity assessed in ml

  at time of hospital stay approx 0.5 days

Interventions

anorectal manometry DEVICE

High-resolution anorectal manometry is done under standard clinical conditions with a 10 cm catheter inserted into the rectum loaded with pressure transducers at a distance of 6 mm in the sphincter area and an attached latex balloon at the catheter tip. It will measure the length of the anal sphincter, the static pressure and the clamping pressure during at least 3 over 40 seconds sustained maneuvers according to a standardized protocol. Mean and maximum pressure increase over the resting pressure during the first 30 seconds of the squeeze and the maximum possible squeeze time will be documented. Moreover, the initial anorectal perception threshold, the perception of urge to defecate and maximum tolerable volume balloon will be documented.

Also known as: AHRM

barostat DEVICE

For the barostat study a balloon will be attached to the catheter. Instead of a barostat machine a 60ml syringe and a sphygmomanometer will be connected to the catheter and the catheter will be positioned in the rectum. The balloon is then dilated gradually to assess perception, urge and discomfort threshold in relation to rectal volume.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women between 18 and 65 years of age without gastrointestinal disease needing medical or surgical treatment.
• No medication (with the exception of occasional intake of paracetamol)
• Availability of all investigations (high resolution anorectal manometry, anorectal barostat with short and standard protocol, proctoscopy and endoanal ultrasound to assess sphincter morphology)
• Good communication with study doctor and meeting of all study requirements.
• Written consent after detailed explanation of study.

You may not qualify if:

• Gastrointestinal symptoms especially fecal incontinence and obstructed defecation
• Structural or functional changes of upper and lower GI Tract (i.e gastric ulcer, malignancy , symptoms of IBS)
• Symptomatic or manometrically diagnosed motility disorders of the upper and lower GI tract for example anismus
• Surgery or interventions in the lower and upper GI tract (appendectomy and hernia excluded) included congenital malformations
• Pelvic radiation therapy
• Fecal incontinence, defined as involuntary loss of liquid or hard stool
• Functional defecation disorders as defined by the ROME III criteria.
• Pregnancy with history of vaginal delivery.
• Acute or chronic disease ( for example IBD)
• Malignancy
• Intake of medication one week prior to study begin. Anticoagulants and medication influencing GI motility like prokinetics, calcium channel blockers and antibiotics
• Drug or alcohol use
• Pregnancy and lactation

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Sauter M, Heinrich H, Fox M, Misselwitz B, Halama M, Schwizer W, Fried M, Fruehauf H. Toward more accurate measurements of anorectal motor and sensory function in routine clinical practice: validation of high-resolution anorectal manometry and Rapid Barostat Bag measurements of rectal function. Neurogastroenterol Motil. 2014 May;26(5):685-95. doi: 10.1111/nmo.12317. Epub 2014 Feb 12.

  PMID: 24517865 DERIVED

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

• Heiko Fruehauf, MD

  University Hospital Zurich, Division of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 20, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

CH (1)