An observational study in Chrohn's Disease, sponsored by East Kent Hospitals University NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by East Kent Hospitals University NHS Foundation Trust · Observational
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:
Postoperative recurrence of Crohn's disease frequently occurs at or near the ileocolic anastomosis.1 Increasing evidence suggests that oxidative stress plays a central role in anastomotic healing, fibrosis and mucosal recurrence. Surgical injury triggers neutrophil recruitment and reactive oxygen species (ROS) production, which can initiate lipid peroxidation within intestinal epithelial membranes.3 Lipid peroxidation products such as malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE) activate inflammatory and fibrotic signalling pathways including mitogen-activated protein kinase (MAPK), nuclear factor-κB (NF-κB) and transforming growth factor- β (TGF-β).2,4 GPX4 is a key antioxidant enzyme that detoxifies lipid peroxides and prevents ferroptosis, a regulated form of oxidative cell death.5 Reduced GPX4 activity has been described in inflammatory bowel disease and may contribute to epithelial injury and disease progression.5 Recent results have demonstrated that a reduced GPX4 expression at time of surgery predicts disease recurrence after ileocolonic resection independent of established clinical risk factors (e.g., smoking, penetrating disease, sex and age). Despite the recognised importance of oxidative stress in intestinal inflammation, its role at the surgical anastomosis in Crohn's disease has not been directly studied.
The Kono-S anastomosis is a functional end-to-end, antimesenteric configuration designed to reduce luminal distortion and faecal stasis while excluding mesenteric inflammatory influence. Early studies suggested reduced endoscopic recurrence compared with conventional anastomoses, although long-term clinical results remain mixed.6 The biological mechanisms underlying any benefit remain poorly understood.
The investigators hypothesise that the Kono-S anastomotic configuration may reduce local oxidative stress at the anastomotic site by limiting reactive oxygen species exposure and subsequent lipid peroxidation, as reflected by lower levels of markers such as malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE) compared with conventional techniques. This more favourable redox environment may support preservation of epithelial antioxidant defence mechanisms, including maintenance of glutathione peroxidase-4 (GPX4) expression and activity, thereby reducing susceptibility of intestinal epithelial cells to ferroptosis. In turn, reduced lipid peroxidation may attenuate activation of key pro-inflammatory and pro-fibrotic signalling pathways, including MAPK, NF-κB and TGF-β, with potential downstream effects on mucosal inflammation and fibrotic remodelling.4 Overall, these mechanisms may contribute to improved anastomotic healing and a lower risk of early endoscopic recurrence.
East Kent Hospitals University NHS Foundation Trust is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Crohn's disease undergoing ileocolic resection, for whom suitable archived histopathology material and relevant clinical data are available.
Inclusion Criteria:• Adults (≥18 years) with confirmed Crohn's disease who underwent ileocolic or small bowel resection with a primary anastomosis.
Exclusion Criteria:
Indeterminate colitis or non-Crohn's pathology on histology.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Kono\_S anastomotic technique after following ileocolic resection for Crohn's disease
conventional anastomotic techniques following ileocolic resection for Crohn's disease
• 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)
Time frame: 6-12 months after IC resection.
• 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?
Time frame: 6-12 months after IC resection
• 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
Time frame: 6-12 months after IC resection
• Association between GPX4 and histological inflammation, fibrosis/stricture phenotype, or restenosis.
• Association between GPX4 and histological inflammation, fibrosis/stricture phenotype, or restenosis.
Time frame: 6-12 months after IC resection
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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East Kent Hospitals University NHS Foundation Trust