Obesity
Conditions
Interventions
BOCABS is an observational study of patients undergoing weight loss surgery.
Pre-operatively participants will have anthropometric measurements. A food portion size estimation interview will be carri
Sponsors
Northumbria Healthcare NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Epigenetic markers (Wnt signalling pathway) measured using pyrosequencing 2. Gene expression (Wnt signalling pathway) measured using qPCR 3. Mucosal expression of inflammatory markers measured using qPCR and/or immunohistochemistry All secondary outcomes will be measured at baseline for all participants and repeated at 6 months for those who have bariatric surgery. | — |
Countries
United Kingdom
Outcome results
None listed