Biomarkers Of Colorectal cancer After Bariatric Surgery

Completed

• Conditions: Obesity; Colorectal cancer; Bariatric surgery; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN95459522
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28990150

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-19
• Study Completion: 2016-04-30
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Current inclusion criteria as of 11/12/2014:
Intervention group:
Obese adult patients planned for bariatric surgery

Control group:
Healthy adult patients with a normal Body Mass Index (18.5 to 24.9 kg/m2) and a recent (within 1 year) normal endoscopic (colonoscopy or flexible sigmoidoscopy) examination.

Previous inclusion criteria:
Intervention group:
Obese adult patients planned for bariatric surgery

Control group:
?Healthy? adult patients with a ?normal? Body Mass Index (18.5 to 24.9 kg/m2) and either:
1. A recent (within 6 months) normal colonoscopy undergoing minor anorectal surgery
2. The need for a rigid sigmoidoscopy & completion colonoscopy, as part of routine care

Exclusion Criteria

Pre-bariatric surgery/controls:
1. Age under 16 years old or over 65 years old
2. Previous colorectal resection
3. Previous weight loss surgery
4. Active or previous history of any type of Inflammatory Bowel Disease
5. Familial adenomatous polyposis
6. Lynch syndrome (Amsterdam II criteria)
7. Steroids, except topical, or other immunosuppressive medication
8. Warfarin or other anticoagulation
Added 11/12/2014: 9. Pregnancy

Post-bariatric surgery:
1. Major post-operative complications (defined using Clavien-Dindo classification =3)
2. Pregnancy

Exclusion based on rigid sigmoidoscopy findings:
1. Difficulty in performing rigid sigmoidoscopy, either due to anal pathology or other technical difficulty
2. Macroscopically abnormal rectal mucosa
3. Unexpected microscopic abnormality on histological examination of rectal biopsies (e.g. microscopic colitis)

Removed as of 11/12/2014:
Additional exclusion for the 'normal weight' healthy controls:
1. Significant pathology on follow-up colonoscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epithelial cell kinetics of rectal mucosa measured using direct counting of mitotic figures after crypt microdissection; at baseline and repeated at 6 months for those who have bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
1. Epigenetic markers (Wnt signalling pathway) measured using pyrosequencing<br>2. Gene expression (Wnt signalling pathway) measured using qPCR<br>3. Mucosal expression of inflammatory markers measured using qPCR and/or immunohistochemistry<br><br>All secondary outcomes will be measured at baseline for all participants and repeated at 6 months for those who have bariatric surgery.