Studies in Patients With Defecatory Disorders

NCT03317938 | Completed

• 1 other identifier: 2017.122
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief Summary

Defecatory disorders like chronic constipation and faecal incontinence affect 25% of the population with rising incidence. Defecatory disorders pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial. Current assessment of patients with constipation and faecal incontinence include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess patients' pelvic floor anatomy and anorectal manometry and balloon expulsion test to assess anorectal function. All tests are susceptible to measurement artifacts. The standard technologies for anorectal assessment are anorectal manometry, balloon expulsion test and defecography. Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology, originally used to measure the dimensions and function of a hollow organ. Anorectal manometry, balloon expulsion test, defecography, and the EndoFLIP probe will be used in the proposed studies. In addition, the proposed study intends to use a simulated feces named Fecobionics which is a device that integrates several technologies into one which will save time and reduce test variability. In the proposed studies investigators will assess defecatory function in subgroups of Hong Kong patients suffering from chronic constipation and faecal incontinence and determine biomarkers to increase the diagnostic value of anorectal testing. Investigators will study up to 130 patients with anorectal disorders and 101 healthy control subjects. Investigators anticipate to improve diagnostics of anorectal disorders considerably and to learn about physiological mechanisms that affect defecatory efficacy.

Conditions

Fecal Incontinence; Constipation

Outcome Measures

Primary Outcomes (1)

• Decreased anorectal pressure assessed with the Fecobionics device

  The number of participants with low anorectal pressure during defecation

  1 year

Secondary Outcomes (3)

• Decreased anorectal mechanical stress assessed with the Fecobionics device

  1 year

• Decreased anorectal angle assessed with the Fecobionics device

  1 year

• Wave-like decrease in cross-sectional area with the Fecobionics device

  1 year

Study Arms (1)

Fecobionics studies

EXPERIMENTAL

Device: Fecobionics

Interventions

Fecobionics DEVICE

Fecobionics is a new device for studying defecation

Fecobionics studies

Eligibility Criteria

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

You may qualify if:

• Healthy subjects: Asymptomatic healthy persons aged over 18 years who can give informed consent.
• CC (Chronic Constipation) Patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
• FI (Fecal Incontinence) patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
• Patients with a stoma who are over 18 years and able to give consent.

You may not qualify if:

• Healthy subjects: Persons with a history of constipation or fecal incontinence, prior abdominal surgery, medication, and diseases, especially chronic diseases that affect bowel function and defecation. Pregnant women will also be excluded.
• CC Patients: Patients, who are not willing to undergo the proposed test program and patients with prior anorectal or intestinal surgery. Pregnant women and patients with chronic dehydration and on medications like opioids will also be excluded.
• FI patients: 1) Patients who are not willing to undergo the specified tests in this study, 2) Pregnant women and 3) Patients who has had anorectal surgery or bowel resection.
• Patients with stoma: Patients, who are not willing to undergo the proposed test program and patients who have inflammation or symptoms related to the stoma.

Sponsors & Collaborators

• Giome: lead

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong, 000000, Hong Kong

Location

Department of Surgery, Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (4)

• Futaba K, Chen SC, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence. Clin Transl Gastroenterol. 2022 May 1;13(5):e00491. doi: 10.14309/ctg.0000000000000491.

  PMID: 35363631 DERIVED

• Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Daming S, Futaba K. Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool. Clin Transl Gastroenterol. 2021 May 5;12(5):e00354. doi: 10.14309/ctg.0000000000000354.

  PMID: 33949343 DERIVED

• Chen SC, Futaba K, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. Tech Coloproctol. 2021 May;25(5):559-568. doi: 10.1007/s10151-021-02439-2. Epub 2021 Mar 29.

  PMID: 33779850 DERIVED

• Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Futaba K. Novel Fecobionics Defecatory Function Testing. Clin Transl Gastroenterol. 2019 Dec;10(12):e00108. doi: 10.14309/ctg.0000000000000108.

  PMID: 31800543 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Constipation

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 23, 2017
• Study Start: August 14, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

HK (2)