COlonic Salvage by Therapeutic Appendectomy. — COSTA  

Colitis, Ulcerative Clinical Trial

Official title: The Effect of Appendectomy in Ulcerative Colitis Patients With Active Disease: COlonic Salvage by Therapeutic Appendectomy

Status Recruiting

Clinical Trial Summary

Rationale: The annual incidence of ulcerative colitis (UC) amounts to 6-8 new cases per 100.000. Patients are initially treated medically, and colitis refractory to medical management is treated surgically, mostly by means of an (emergency) colectomy or a proctocolectomy with ileal J-pouch anastomosis. Over the past 10 years evidence has been accumulating indicating that the appendix has an immunomodulatory role in patients with UC reducing the need for medication and perhaps even colectomy.

Objective: The objective of this prospective observational cohort study is to evaluate the effect of appendectomy on the disease course of patients with active ulcerative colitis despite standard step-up treatment including biologicals. The second objective is to determine if histological inflammation in the appendix resection specimens can be reliably predicted by pre-operative endoscopic biopsies of the appendix and correlated to clinical and pathological response after appendectomy.

Study design: The design of the study is a prospective observational cohort study of 80 consecutive patients.

Study population: Sixty patients of 18 years and older, with established diagnosis of UC and ongoing disease activity despite standard step-up treatment including biologicals. Furthermore, histological characteristics in appendix biopsies of 10 patients with non-active UC and 10 'healthy control' patients (e.g. patients undergoing endoscopy for polyps) will be evaluated and used as a reference control group.

Intervention: Patients will undergo laparoscopic appendectomy in clinical or day care setting.

Main study parameters/objectives: The primary outcome parameter is the number of patients achieving remission (Total Mayo score ≤2) 12 months after appendectomy. Secondary endpoints are reduction of medical therapy, the disease activity as measured with the Mayo score, colectomy rate, the health related quality of life and costs (EQ-5D, EORTC-QLQ-C30-QL and IBDQ), and histological appendix characteristics predictive of response.

Clinical Trial Description

The study is designed as a prospective observational series including patients with active ulcerative colitis despite standard step-up treatment including biologicals. Sixty consecutive patients who are refractory to medical treatment will be recruited to evaluate the effect of the appendectomy on the disease course.

Eligible patients will be counselled at the outpatient clinics. Patients with presumed therapy-refractory inflammation will undergo ileocolonoscopy, which is part of standard daily practice. When informed consent is given, the presence of a PARP will be documented, and additional biopsies of the appendix and coecal base will be taken, to determine histological inflammation grade. Active disease is required for inclusion, and is defined as a combined clinical and endoscopic Mayo-score of ≥5 with an endoscopic subscore of 2 or 3. After inclusion, a laparoscopic appendectomy will be performed within 9 weeks. Patients will be followed every 3 months after laparoscopic appendectomy to assess the patients' clinical condition and the non-invasive Mayo score. According to standard practice evaluating therapy change, a sigmoidoscopy will be performed within 6 months and a full ileocolonoscopy at 12 months, including biopsies of the colon and coecal base, to assess mucosal appearance and complete the Mayo score.

Postoperatively, patients will receive the similar medical treatment as given pre-appendectomy. If medication can be tapered post-appendectomy, this will be done according to the experience of the treating physician and current guidelines. Patients will complete health related quality of life questionnaires (EQ-5D, EORTC-QLQ-C30-QL and IBDQ) via email or a telemedicine application (MyIBDcoach) at inclusion and at 3, 6 and 12 months follow-up.

The pre-operative endoscopic biopsies of the appendix will be used to determine if histological inflammation in the appendix resection specimens can be reliably predicted. Histological findings in the resection specimens will be correlated to clinical and pathological response after appendectomy. Furthermore, in 20 patients who are planned for colonoscopy (10 patients with non-active UC and 10 non-UC patients with polyps) additional appendix biopsies will be taken to use as a reference control group. Therefore, a total of 80 patients will be recruited for this study. ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

• NCT number: NCT03912714
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Willem Bemelman, MD, PhD
• Phone: 0031207326818
• Email: w.a.bemelman@amc.nl
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2018
• Completion date: September 2020