Ileal Pouch Microbiome Study: defining a pre-operative microbiological signature that predisposes to anastomotic leak

Not Applicable

• Conditions: lcerative Colitis; Ulcerative Colitis; Surgery - Other surgery; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12620000484943
• Lead Sponsor: Royal Brisbane Womens Hospital (RBWH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Ileal pouch surgery without a covering loop ileostomy
J, W or S pouch configuration
Indication must be Ulcerative Colitis
Must be staged (ie. prior total colectomy and ileostomy)

Exclusion Criteria

Age less than 18 years
Inability to give consent
Pregnant

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome profiles in stool.<br>Microbiome profiles in stool will be assessed by 16S rRNA and metagenomic sequencing of microbial genera and species. [Day of surgery (Day 0)];Microbiome sequence profiles in ileal and rectal tissue<br>A biopsy will be collected from the surgical specimen of rectum and ileum and stored frozen at -80 degrees Celcius until assessment of microbial genera and species. Microbial profiles will be assessed by 16S rRNA sequencing[Day of surgery (Day 0) ];Collagenase levels in stool.<br>Collagenase functional activity will be measured by Immuno-assasy (ELISA)<br>Collagenase genomic levels in stool will be measured by metagenomic sequencing[Day 0 (day of surgery)]

Secondary Outcome Measures

Name	Time	Method
Pouchitis<br>Pouchitis will be assessed by clinical examination and pouchoscopy[ After discharge from hospital post surgery (at regular follow up appointments 6 weeks, 6 months, 12 months, 18 months)];fistulating perianal disease<br>Examined by clinical examination and pelvic imaging (CT scan)<br>[6 weeks post surgery and at each postsurgical follow up appointment (6 months, 12 months, 18 months)<br>];Anastomotic leak following surgery<br>Anastomotic leak will be assessed by clinical examination together with blood tests and CT scan[Day 1, Day 2, Day 3, Day 4 and Day 5, post surgery during hospital admission]