Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT
Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT
There is currently no standard management to guide the clinicians in treating patients with
 fibrostenotic disease. European Crohns and Colitis Organization [ECCO] recently developed a
 topical review on prediction, diagnosis and management of fibrostenosing Crohns disease. The
 review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as
 reasonable treatment options for short strictures based on the low grade of evidence.
Study Population All patients with Crohns disease and a short stricture (<5 cm) within the
 reach of upper or lower GI endoscopy

 Study Timeline

 1. Pre-recruitment phase including proposal, IRB approval, staff training, budget transfer
 - 9 months

 2. Recruitment of patients: 2 years

 3. Follow up: 2 years

 4. Analysis and preparing report: 6 months

 Study Design Single blind randomized controlled trial The data will be blindly analyzed.
 Double blinding is not possible due to the nature of the study.

 Study Methods Please see the study flow diagram below. Randomization will be done using
 computer software generating random numbers. Outcome Measures - A research associate will
 contact patients on weeks 1,2,4 and months 3,6,12,18 and 24 to record the items mentioned as
 secondary objectives of the study.

 - An interim analysis will be performed after 20 cases complete the study Sample Size 40
 patients randomized to two arms undergoing TTS dilation or surgical managements

 Statistical analysis Comparisons between groups will be done using Student's t-test.
 Qualitative variables will be summarized as a percentage of the group total and comparisons
 between groups will be based on the chisquared test. The cumulative relapse rate of each
 treatment group will be estimated by the Kaplan±Meier method and the difference between
 treatment groups will be tested by the log rank test. Time to relapse will be compared
 betweens two groups using a Cox proportional hazards regression analysis. A P value of less
 than 0.05 is considered to be signicant.
Inclusion Criteria:

 -  40 Patients with Crohns disease and a short stricture (<5 cm) within the reach of
 upper or lower GI endoscopy

 Exclusion Criteria:

 -  Abscess or phlegmon

 -  Fistula

 -  High-grade dysplasia

 -  Malignancy

 -  Previous intervention

 -  Pregnant women