About this trial
Crohn's disease is a long-term condition that causes inflammation in the bowel. Many people with Crohn's will need surgery at some point to remove damaged sections of intestine. Although surgery can improve symptoms, the disease often comes back near the join (anastomosis) where the bowel has been reconnected.
Surgeons use different techniques to reconnect the bowel. One newer approach, called the Kono-S anastomosis, is designed to reduce the risk of Crohn's disease returning. Early results are promising, but it is still not fully understood why it may work better than traditional methods.
This project aims to explore how the bowel heals after surgery by looking at oxidative stress, a type of tissue damage caused by an imbalance of harmful molecules in the body. The investigators will focus on a protective protein called glutathione peroxidase-4 (GPX4), an anti-oxidative enzyme that reduces oxidized phospholipids in biomembranes.
By analysing tissue samples taken before and after surgery, the investigators will compare patients who had the Kono-S technique with those who had standard surgical joins. The investigators want to see whether differences in healing at a microscopic level could explain why some patients do better than others.
The findings from this study could:
* Improve understanding of why Crohn's disease comes back after surgery. * Help surgeons choose the best technique for each patient. * Support the development of new treatments aimed at improving healing. Ultimately, this research aims to reduce the risk of disease recurrence and improve long-term outcomes for people living with Crohn's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented anastomotic configuration (Kono-S or conventional).
Availability of archived pathology material from the resection specimen containing the anastomotic site.
At least one additional tissue timepoint available: preoperative endoscopic biopsy or follow up endoscopic biopsy within 24 months.
Available postoperative endoscopic follow up data (Rutgeerts score) where applicable.
Disqualifiers
• Indeterminate colitis or non-Crohn's pathology on histology.
Lack of retrievable tissue or poor tissue quality (e.g., extensive necrosis or autolysis) precluding IHC.
Unclear anastomotic type.
Absence of epithelial component in the available tissue (e.g., only serosa or fibrofatty tissue).
Trial population
Crohn's disease undergoing ileocolic resection, for whom suitable archived histopathology material and relevant clinical data are available.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
• Difference in epithelial GPX4 expression score between Kono-S and conventional groups at the anastomotic site 6-12 months after IC resection.
• Difference in epithelial GPX4 expression score between Kono-S and conventional groups at the anastomotic site 6-12 months after IC resection. The scale consists of n- not detected ( high reoccurrence risk) l- low level (high reoccurrence risk) m-medium level (low reoccurrence risk) h-high level (low reoccurrence risk)
Secondary outcomes
• Association between GPX4 expression and Rutgeerts score / endoscopic recurrence
• Association between GPX4 expression and Rutgeerts score / endoscopic recurrence. Rutgeerts score i0- no lesions (best outcome) i1- not more than 5 lesions i2 \>5 lesions i3 \>5 lesions i4 \>5 lesions (worst outcome) is the accepted score. Is there any correlation with the levels of GPX4 (n/l/m,h) in the participants?
• Within patient change in GPX4 across pre-operative, operative and follow up tissues
• Within patient change in GPX4 across pre-operative, operative and follow up tissues
• Association between GPX4 and histological inflammation, fibrosis/stricture phenotype, or restenosis.
• Association between GPX4 and histological inflammation, fibrosis/stricture phenotype, or restenosis.
Sponsors and contacts
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