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MRI in Normal Ileal Pouches, and a Feasibility Study of Dynamic MRI Enema and Defaecating MRI Pouchography

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ClinicalTrials.gov Identifier: NCT02925260
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
London North West Healthcare NHS Trust

Brief Summary:
A study to investigate the prevalence of pelvic collections in a representative sample of participants with normally functioning ileal pouches. It also aims to establish the feasibility and reporting variables for dynamic MRI enemas in ileal pouches and defaecating enema pouchography.

Condition or disease Intervention/treatment
Colitis, Ulcerative Ileal Pouches Other: MRI with ileal pouch contrast and enema.

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pelvic Collections on MRI in Patients With Ileal Pouches, and a Feasibility Study of Dynamic MRI Enema and Defaecating MRI Pouchography
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Group/Cohort Intervention/treatment
Patients with normal ileal pouches

Inclusion Criteria

  • Ileal pouch reservoir in situ
  • Greater than three years since closure of ileostomy
  • Normal pouch function as defined by Orësland score of <4
  • Never had a diagnosis of pouchitis
  • Never had treatment for pouchitis
  • No evidence of pouchitis on rigid pouchoscopy
  • CRP <10
Other: MRI with ileal pouch contrast and enema.
Pre enema 20mg IV or IM Hyoscine Butylbromide (Buscopan) Pre enema Small Field of View (SFOV) T2 sagittal series Pre enema SFOV T2 axial series Pre enema SFOV T1 sagittal series (fat suppressed) Pre enema SFOV T1 axial series (fat suppressed) Enema infiltration started During enema filling Dynamic T1 sagittal single image, fat suppressed, aligned on pouch-anal anastomosis During enema filling T1 sagittal series (fat suppressed) During enema filling T1 axial series (fat suppressed) Jelly infiltrated and held Evacuating series Oblique sagittal T2 evacuating series of the mid and distal pouch, aligned to the pouch-anal anastomosis




Primary Outcome Measures :
  1. The prevalence of pelvic collections in a representative sample of patients with normally functioning ileal pouches. [ Time Frame: Baseline ( MRI scan) ]

Secondary Outcome Measures :
  1. A descriptive assessment of the normal variation of ileal pouches on MRI scans. [ Time Frame: Baseline ( MRI scan) ]
  2. Assess the patient experience of MRI pouchography using enemas [ Time Frame: Baseline ( MRI scan) ]
    Non-validated questionnaire assessment of patient anxiety, comfort, embarrassment and confidence in the outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ulcerative colitis who have had an ileal pouch formed and never had any septic or inflammatory complications, at least three years from reversal of ileostomy.
Criteria

Inclusion Criteria:

  • • Ileal pouch reservoir in situ

    • Greater than three years since closure of ileostomy
    • Normal pouch function as defined by Orësland score of <4
    • Never had a diagnosis of pouchitis
    • Never had treatment for pouchitis
    • No evidence of pouchitis on rigid pouchoscopy
    • CRP <10

Exclusion Criteria:

  • • Contraindications to magnetic resonance imaging (MRI) See appendix 1.

    • Unable or unwilling to agree to informed consent
    • Known inability to tolerate MRI (e.g. impaired mobility or claustrophobia)
    • Known gadolinium allergy
    • Known inability to maintain anal continence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925260


Contacts
Contact: Guy HT Worley, BMBS MRCS +44 07984680155 guy.worley@nhs.net

Locations
United Kingdom
St Mark's Hospital Recruiting
London, Middlesex, United Kingdom, HA1 3UJ
Contact: Guy Worley, BMedSci BMBS MRCS    +4407984680155    guy.worley@nhs.net   
Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Principal Investigator: Guy HT Worley, BMBS MRCS St Mark's Hospital
Study Chair: Susan K Clark, PhD St Mark's Hospital

Publications:
NICE Centre for Clinical Practice. Ulcerative colitis: the management of ulcerative colitis. 2011;(June):1-68.
Parks AG, Nicholls RJ, Belliveau P. Proctocolectomy with ileal reservoir and anal anastomosis. Br J Surg [Internet]. John Wiley & Sons, Ltd.; 1980;67(8):533-8. Available from: http://dx.doi.org/10.1002/bjs.1800670802
Ryoo S-B, Oh H-K, Han EC, Ha H-K, Moon SH, Choe EK, et al. Complications after ileal pouch-anal anastomosis in Korean patients with ulcerative colitis. World J Gastroenterol [Internet]. United States: Ryoo,Seung-Bum. Seung-Bum Ryoo, Heung-Kwon Oh, Eon Chul Han, Heon-Kyun Ha, Sang Hui Moon, Eun Kyung Choe, Kyu Joo Park, Division of Colorectal Surgery, Department of Surgery, Seoul National University College of Medicine, Seoul 110-744, South Korea.; 2014;20(23):7488-96. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=24966620
Sherman J, Greenstein AJ, Greenstein AJ. Ileal j pouch complications and surgical solutions: a review. Inflamm Bowel Dis [Internet]. United States: Sherman,Jingjing. Division of Colorectal Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, New York.; 2014;20(9):1678-85. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=24983986
R. M, N. S, M. B, E. R. Pouch function and quality of life after successful management of pouch-related septic complications in patients with ulcerative colitis [Internet]. Langenbeck's Archives of Surgery. R. Mennigen, Department of General and Visceral Surgery, University Hospital Muenster, Waldeyerstr. 1, Muenster 48149, Germany. E-mail: rudolf.mennigen@ukmuenster.de: Springer Verlag (Tiergartenstrasse 17, Heidelberg D-69121, Germany); 2012. p. 37-44. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed10&NEWS=N&AN=2011655737
Sugerman HJ, Sugerman EL, Meador JG, Newsome HHJ, Kellum JMJ, DeMaria EJ. Ileal pouch anal anastomosis without ileal diversion. Ann Surg [Internet]. UNITED STATES: Sugerman,H J. General/Trauma Surgery Division, Department of Surgery, Medical College of Virginia of Virginia Commonwealth University, Richmond, Virginia, USA. hsugerma@hsc.vcu.edu; 2000;232(4):530-41. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med4&NEWS=N&AN=10998651
Soto J a, Gupta A, Broder JC, Tkacz JN, Anderson SW, Soto J a, et al. Ileal pouch-anal anastomosis surgery: imaging and intervention for post-operative complications. Radiographics [Internet]. United States: Broder,Jennifer C. Department of Radiology, Boston University Medical Center and Boston University, 820 Harrison Avenue, Boston, MA 02118, USA. jennifer.broder@bmc.org; 2010;30(1):221-33. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med5&NEWS=N&AN=20083595

Responsible Party: London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02925260     History of Changes
Other Study ID Numbers: mripouchesv1.11808216
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Any data published will be fully anonymised. Identifiable patient data will be shared between the two sites conducting the research, this will be via secure email server. This arrangement is subject to UK Research and Ethics Committee scrutiny.

Additional relevant MeSH terms:
Colitis, Ulcerative
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases