The Effect of Appendectomy in Ulcerative Colitis patients with active disease: COlonic Salvage by Therapeutic Appendicectomy (COSTA study)

Recruiting

Conditions: inflammatory bowel disease
Ulcerative colitis
10017969

Registration Number: NL-OMON52601

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 134

Inclusion Criteria

- Age 16 years and older
- Established diagnosis of ulcerative colitis
- Active disease (defined both clinically and endoscopically as Mayo-score >=5
with endoscopy score of 2 or 3) despite standard step-up treatment including
optimized biological treatment
- Obtained written informed consent

Exclusion Criteria

- Prior appendectomy or other abdominal surgery.
- Any suspicion of Crohn*s disease.
- Toxic megacolon
- Patients with active extra-intestinal infections, liver or kidney failure,
mayor lung and heart co-morbidity.
- Insufficient command of Dutch or cognitively unable to complete Dutch
questionnaires
- Daily dosage of oral prednison equal to or higher than 20 mg
- History of dysplasia and/or cancer in bowel

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Steroid-free remission rate (total mayo score <=2 with no subscore exceeding 1)<br /><br>12 months after appendectomy without switch of therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time to remission<br /><br>- Endoscopic disease activity after 6 and 12 months, measured with the Mayo<br /><br>score<br /><br>- Reduction of medical therapy including corticosteroids<br /><br>- Failure (upscaling of medication, start trial medication or colectomy)<br /><br>- Biological free remission<br /><br>- Global, health related, and disease specific quality of life<br /><br>(EORTC-QLQ-C30-QL, EQ-5D-5L, and IBDQ)<br /><br>- Patient self-reported assessment of symptomatology (MYMOP score)<br /><br>- Percentage of patients interested in appendectomy after counselling<br /><br>- Cost-effectiveness<br /><br>- Radiological analysis of preoperative ultrasound images of the appendix to<br /><br>determine characteristics predictive of response. The main<br /><br>- Pathological analysis of coecal biopsies and resection specimen to determine<br /><br>histological characteristics predictive of response.</p><br>