The objective of this prospective observational series is to evaluate the effect of appendectomy on the disease course of ulcerative colitis patients with active disease despite standard step-up treatment including optimized biological treatment.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Steroid-free remission rate (total mayo score <=2 with no subscore exceeding 1)
12 months after appendectomy without switch of therapy.
Secondary outcome
- Time to remission
- Endoscopic disease activity after 6 and 12 months, measured with the Mayo
score
- Reduction of medical therapy including corticosteroids
- Failure (upscaling of medication, start trial medication or colectomy)
- Biological free remission
- Global, health related, and disease specific quality of life
(EORTC-QLQ-C30-QL, EQ-5D-5L, and IBDQ)
- Patient self-reported assessment of symptomatology (MYMOP score)
- Percentage of patients interested in appendectomy after counselling
- Cost-effectiveness
- Radiological analysis of preoperative ultrasound images of the appendix to
determine characteristics predictive of response. The main
- Pathological analysis of coecal biopsies and resection specimen to determine
histological characteristics predictive of response.
Background summary
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.
Study objective
The objective of this prospective observational series is to evaluate the
effect of appendectomy on the disease course of ulcerative colitis patients
with active disease despite standard step-up treatment including optimized
biological treatment.
Study design
Multicenter prospective observational cohort study
Intervention
Laparoscopic appendectomy in day-care setting
Study burden and risks
The 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 6 and 12 months) and the non-invasive 9-point partial Mayo score
(after 3, 6, 12 and 30 months), Health related Quality of life as measured by
the EQ-5D and IBDQ (at inclusion and after 3, 6, 12 and 30 months)
questionnaires, utilization of health care, direct medical and non-medical
costs and friction costs related to leave from work. At day of the operation,
an ultrasound of the appendix will be performed. 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. It is
possible to answer these questions via the myIBDcoach application so no
telephone conversation needs to be scheduled. Patients will minimally be
followed up by the gastroenterologist or the research resident at the
outpatient clinic or per telephone at 6 weeks and 6 and 12 months after
inclusion, other visits are scheduled on indication. After 6 months a
sigmoidoscopy will be performed and after 12 months another colonoscopy to
assess mucosal healing.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62941.018.17 |