Crohn’s disease Digestive System Crohn disease [regional enteritis]
Conditions
Interventions
The trial follows the standard pathway for ileocaecal Crohn’s. Participants are recruited when surgery is deemed appropriate. Potential participants will be discussed at MDT meetings and identified at
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: People aged over 18 years undergoing ileocaecal resection for primary/recurrent Crohn’s disease where an anastomosis is carried out
Exclusion criteria
Exclusion criteria: Participant exclusion criteria as of 10/11/2023: 1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation 2. Patients undergoing stoma formation proximal to the anastomosis 3. Patients who have a contraindication to subsequent colonoscopy 4. Patients unable to give full informed consent 5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care) 6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery Previous participant exclusion criteria: 1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation 2. Patients undergoing stoma formation 3. Patients who have a contraindication to subsequent colonoscopy 4. Patients unable to give full informed consent 5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care) 6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to endoscopic recurrence of disease using the Modified Rutgeerts score (=i2) from the date of randomisation after 6-12 months to a maximum of 3 years follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of severe endoscopic recurrence measured using the Modified Rutgeerts score =i3 after 6-12 months to a maximum of 3 years follow-up 2. Clinician and patient-reported symptomatic recurrence at 6-12 months and at the end of the trial. The definition of symptomatic recurrence will be: 2.1. Self-reported recurrence in combination with endoscopically confirmed recurrence; OR 2.2. Surgical re-intervention in combination with histological confirmation of recurrence; OR 2.3. Change of medical strategy for reasons other than safety/tolerability; OR 2.4. IBD Control >13; OR, Crohn's Disease Activity Index (CDAI) >220 3. Quality of life measured using EQ-5D-5L at 6-12 months after surgery 4. Time to endoscopic recurrence for all groups measured using Modified Rutgeerts score (=i2) for at least 6 months and up to 3 years after surgery 5. Surgical recurrence measured using clinician and patient report at a minimum of 6 months and a maximum of 3 years 6. Radiological and surgical anastomotic leak (following surgery) as defined by the latest consensus; other complications for each intervention (surgical complications may include, but are not limited to haemorrhage; ileus/bowel obstruction; wound infection; urinary tract infection; cardiac events; pulmonary embolism [PE]/deep vein thrombosis [DVT]; and respiratory insufficiency/pneumonia. Late postoperative complications may include: trocar-site and incisional hernia; ureteral stenosis [retroperitoneal fibrosis]) recorded at surgery, following surgery and within at least 6 months and a maximum of 3 years following surgery 7. Mesenteric disease severity measured using the mesenteric disease activity index at surgery | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed