Crohn Disease Clinical Trial
Official title:
Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction. DESIGN Randomised superiority study POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum INTERVENTION Kono S and end to end hand sewn anastomosis USUAL CARE Side to side stapled anastomosis OUTCOME Endoscopic recurrence (local and central reading) at 6 months SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients KEYWORDS Crohn, ileocolic resection, recurrence
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
| Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
| Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
| Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
| Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
| Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
| Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
| Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
| Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
| Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
| Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
| Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
| Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
| Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
| Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 |