Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Surgical resection

    Procedure/Surgery

    The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: EBD groupExperimental treatment 1 intervention
Group B: SEMS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
One year of follow-up

Secondary outcomes

1

Percentage of patients with clinical recurrence

Percentage of patients with clinical recurrence (scale of obstructive symptoms 0-6) and costs. The lower the better.

Time frame
One year of follow-up
2

Percentage of complications

Percentage of complications and costs.

Time frame
One year of follow-up

Other outcomes

Sponsors and contacts

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