Crohn DiseaseNCT03819257
Anorectal Function in Perianal Crohn's Disease
An observational study of Crohn Disease, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Perianal Crohn's disease is a disabling disease associated with increased morbidity and impaired quality of life. It is associated with pain, discharge, fecal incontinence and sexual and psychological impairment. In refractory cases, a stoma may be necessary. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Endoanal ultrasound, High-resolution anorectal manometry and Balloon expulsion test
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2019to 22 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending hospital with diagnosed perianal Crohn's disease.
Who may be able to join
- ≥ 18 and ≤ 75 year-old patients
- CD in clinical remission, defined by a Harvey-Bradshaw index <5
- Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive
- Perianal Disease Activity Index (PDAI) of ≤4
- Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long they fulfill the other inclusion criteria, like for anorectal symptomatic patients having a PDAI≤4
- Endoanal ultrasound without an image compatible with new/non-treated abscess or perianal fistula
- Both previous simple or complex perianal fistula (according to the American College of Gastroenterology) will be considered.
Who cannot join
- Women with previous vaginal delivery
- Ileostomy
- Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy
- Active rectal disease. No rectal involvement will be defined by no previous rectal involvement ever described or if previous involvement, endoscopy within 18 months showing no current involvement
- Previous or current anal fissure
- Anal stricture
- Current or previous rectovaginal fistula (previous/last pelvic MRI).
- A previous seton placement, abscess drainage, fistulotomy and lay open fistula are not an exclusion criteria. Patients with a current seton can only be included if the seton was place more than 24 weeks ago, and the endoanal ultrasound does not show any new/non-treated perianal fistula/abscess.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anorectal Function in Perianal Crohn's Disease: a Pilot Study.
Perianal Crohn's disease is a disabling disease associated with increased morbidity and impaired quality of life. It is associated with pain, discharge, fecal incontinence and sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher prevalence is seen with increasing Crohn's disease duration and appears to vary according to the disease location. The presence of symptoms associated with anorectal dysfunction, such as fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter abnormalities may have important implications for the future selection of type of delivery, and might even pose a contra-indication for certain types of anorectal surgeries.
Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal function are lacking. There is a need for a better understanding of the chronic complications of this disease, and the role of high-resolution anorectal manometry in diagnosing these abnormalities during follow-up of these patients. This study will evaluate the chronic repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or abscess that has healed and/or is inactive.
- Conditions
- Crohn Disease
- Being tested
- Endoanal ultrasound, High-resolution anorectal manometry, Balloon expulsion test
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoanal ultrasoundDiagnostic test
For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.
High-resolution anorectal manometryDiagnostic test
- rest - basal anal pressures at rest over 60 s
- squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort
- cough - anorectal pressure changes during cough
- push - anorectal pressure changes during simulated defecation
- rectoanal inhibitory reflex - reflex anal response to rectal distension
- rectal sensation - assessment of rectal sensitivity to distension.
Balloon expulsion testDiagnostic test
A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.
| Study group | Role | What they receive |
|---|---|---|
| Patients with perianal Crohn's disease. | Not described Receives: Diagnostic Test: Endoanal ultrasound; Diagnostic Test: High-resolution anorectal manometry; Diagnostic Test: Balloon expulsion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension.
Evaluated by high-resolution anorectal manometry.
Measured: 30 minutes
Anal sphincters integrity.
Evaluated by endoanal ultrasound.
Measured: 5 minutes
Ballon expulsion test duration.
Measured: 3 minutes
Secondary outcomes (1)
Presence of symptoms suggesting obstructed defection.
Prolonged and unsuccessful straining at stool, self-digitation for defecation, sense of incomplete evacuation or sensation of anorectal obstruction/blockage and a stool frequency of less than three times per week.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start19 Jan 2019
- Primary completion22 Feb 2020
- Study completion22 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819257
- Sponsor's protocol ID
- GA18/113514
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albuquerque A, Casey J, Fairlamb G, Houghton LA, Selinger C. Evaluation of Anorectal Function in Perianal Crohn's Disease: A Pilot Study. J Clin Med. 2021 Dec 16;10(24):5909. doi: 10.3390/jcm10245909.
PubMed 34945205
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anorectal Function in Perianal Crohn's Disease: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03819257
- Acronym / sponsor ID
- GA18/113514
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 22 Feb 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perianal Crohn's disease is a disabling disease associated with increased morbidity and impaired quality of life. It is associated with pain, discharge, fecal incontinence and sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher prevalence is seen with increasing Crohn's disease duration and appears to vary according to the disease location. The presence of symptoms associated with anorectal dysfunction, such as fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter abnormalities may have important implications for the future selection of type of delivery, and might even pose a contra-indication for certain types of anorectal surgeries.
Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal function are lacking. There is a need for a better understanding of the chronic complications of this disease, and the role of high-resolution anorectal manometry in diagnosing these abnormalities during follow-up of these patients. This study will evaluate the chronic repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or abscess that has healed and/or is inactive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with perianal Crohn's disease. | – | Diagnostic Test: Endoanal ultrasound, Diagnostic Test: High-resolution anorectal manometry, Diagnostic Test: Balloon expulsion test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending hospital with diagnosed perianal Crohn's disease.
Key inclusion criteria (7 listed)
- ≥ 18 and ≤ 75 year-old patients
- CD in clinical remission, defined by a Harvey-Bradshaw index <5
- Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive
- Perianal Disease Activity Index (PDAI) of ≤4
- Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long they fulfill the other inclusion criteria, like for anorectal symptomatic patients having a PDAI≤4
Key exclusion criteria (8 listed)
- Women with previous vaginal delivery
- Ileostomy
- Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy
- Active rectal disease. No rectal involvement will be defined by no previous rectal involvement ever described or if previous involvement, endoscopy within 18 months showing no current involvement
- Previous or current anal fissure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoanal ultrasoundFor the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement. | Diagnostic test | Patients with perianal Crohn's disease. |
| High-resolution anorectal manometry1. rest - basal anal pressures at rest over 60 s 2. squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort 3. cough - anorectal pressure changes during cough 4. push - anorectal pressure changes during simulated defecation 5. rectoanal inhibitory reflex - reflex anal response to rectal distension 6. rectal sensation - assessment of rectal sensitivity to distension. | Diagnostic test | Patients with perianal Crohn's disease. |
| Balloon expulsion testA non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach. | Diagnostic test | Patients with perianal Crohn's disease. |
Primary outcome
Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension.
Time frame: 30 minutes
Evaluated by high-resolution anorectal manometry.
Anal sphincters integrity.
Time frame: 5 minutes
Evaluated by endoanal ultrasound.
Ballon expulsion test duration.
Time frame: 3 minutes
1 secondary outcome
Presence of symptoms suggesting obstructed defection.
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 34945205Albuquerque A, Casey J, Fairlamb G, Houghton LA, Selinger C. Evaluation of Anorectal Function in Perianal Crohn's Disease: A Pilot Study. J Clin Med. 2021 Dec 16;10(24):5909. doi: 10.3390/jcm10245909.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension. (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.