The effect of appendectomy on the clinical course of Ulcerative colitis: a randomized multicenter trial

The annual incidence of ulcerative colitis (UC) amounts to 6-8 new cases per
100,000. Patients are intentionally treated medically and colitis refractory to
medical management is treated surgically, mostly by means of an emergency
colectomy or elective 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 even colectomy. The concept that appendectomy may modulate the disease
avoiding medical and surgical treatment, and costs is very appealing and
exciting. This is especially true for appendectomy, as this is a relatively
simple procedure that can be performed in day care.

The objective of this study is to evaluate the short-term and medium-term
effectiveness of appendectomy to maintain remission in patients with an
established diagnosis of ulcerative colitis treated for a relapse, but never
treated with biologicals.

The design of the study is a multicenter prospective randomised study.

Patients will be randomized to laparoscopic appendectomy or to no appendectomy
in day care setting.

Both groups of patients will be followed for one year by the medical staff and
trial nurses in order to monitor morbidity of treatment, use of medication or
necessity of surgery, disease activity as measured by endoscopy (at inclusion
and after 12 months) and the non-invasive 9-point partial Mayo score (after 3,
6, 9 and 12 months), Health related Quality of life as measured by the EQ-5D,
EORTC-QLQ-C30-QL, IBDQ (at inclusion and every 3 months thereafter), aglobal
change question* will be asked at 12 months follow- up (*Since the start of the
study, have your UC symptoms improved overall?*), questionnaires, utilization
of health care, direct medical and non-medical costs and friction costs related
to leave from work. Patients will be contacted by telephone every 3 months by a
trial nurse to assess medication usage, complications, additional
interventions, re-admissions, duration of hospital stay and visits to the
outpatient clinic, number of days of sick leave and of social in attendance and
to ensure completions of the questionnaires.
Patients will minimally be followed up by the gastroenterologist or the
research resident at the outpatient clinic or per telephone at 6 weeks and 3,
6, 9 and 12 months after inclusion, other visits are scheduled on indication.
At the end of the study period, after 12 months, a second colonoscopy will be
performed to assess mucosal healing. In the 5 years following the study the
gastroenterologists will be asked to measure the non-invasive 9-point partial
Mayo score every 6 months during outpatient clinic appointments.