About this trial
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years of age.
Crohn's disease with predominantly de novo fibrotic stenosis* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion.
Symptomatology of intestinal occlusion-subocclusion.
Disqualifiers
No informed consent from the patient.
Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
Patients with known stenosis previously treated with stenting and/or dilation performed < 1 year before the date of inclusion.
Pregnancy or lactation.
Trial design
Parallel
Treatments tested in this trial
Surgical resection
Procedure/SurgeryThe type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
Treatment groups
Trial outcomes
Primary outcomes
Quality of life of patients
Percentage of patients with an increase of more than 30 points in the Inflammatory Bowel Disease Questionnaire (IBDQ-32) quality of life index. The higher the better.
Secondary outcomes
Percentage of patients with clinical recurrence
Percentage of patients with clinical recurrence (scale of obstructive symptoms 0-6) and costs. The lower the better.
Percentage of complications
Percentage of complications and costs.
Sponsors and contacts
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