| Objective: |
Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment. |
| Aim: |
The annual incidence of ulcerative colitis amounts to 6-8 new cases per 100,000. The majority of these patients currently needs lifelong treatment with medication including biologicals and 10-20 per cent of the patients requires colectomy within one year. Up to 30%-40% of patients with UC ultimately require surgery. The purpose of the current study is to assess prospectively whether laparoscopic appendectomy alters the course of ulcerative colitis and to study histological and immunological characteristics of the resected appendices from UC patients compared to several control groups. The study is a multicenter study comparing patients between 18 and 80 years with newly diagnosed mild to moderate ulcerative colitis that have been treated medically for their first relapse with 5–ASA preparations and/or corticosteroids. Once clinical and endoscopic remission has been attained, patients will be randomized (1:1) to undergo an elective and ambulatory laparoscopic appendectomy in day care setting. The primary endpoint is the one year cumulative UC relapse rate in both groups. |
| Methods: |
These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score 3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm. |
| Reason for International Trial: |
. |