Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion criteria (study group)
- - Age 18 years and older - Established diagnosis of UC - Active disease (defined both clinically and endoscopically as Mayo-score ≥5 with endoscopy score of 2 or 3) despite standard step-up treatment including biologicals - Obtained written informed consent Inclusion criteria (control group) - Age 18 years and older - UC patients with non-active disease (defined both clinically and endoscopically as Mayo-score ≤5 with endoscopy score of 0 or 1) or non-UC patients with polyps - Planned colonoscopy - Open appendix lumen with diameter large enough to slide scope in - Obtained written informed consent Exclusion criteria (study group) - Prior appendectomy or other abdominal surgery by laparotomy.
- - Suspicion of Crohn's disease.
- - Toxic megacolon or severe acute colitis necessitating clinical admission - 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 Exclusion criteria (control group) - Prior appendectomy.
- - Suspicion of Crohn's disease.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Christianne Buskens, MD, PhD|
|Principal Investigator Affiliation||Amsterdam Medical Centre|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Experimental: Laparoscopic appendectomy
Laparoscopic appendectomy in therapy refractory ulcerative colitis patients after pre-operative endoscopic biopsies of the appendix
Active Comparator: Non-active UC
Patients with non-active ulcerative colitis planned for surveillance colonoscopy will have additional endoscopic appendix biopsies to evaluate the histological characteristics of the appendix.
Active Comparator: Healthy control
'Healthy control' patients (i.e. patients planned for colonoscopy for polyps) will have additional endoscopic appendix biopsies to evaluate the histological characteristics of the appendix.
Procedure: - Laparoscopic appendectomy
Surgery will be performed under general anaesthesia. The laparoscopic appendectomy can be performed with the use of 3 trocars; one subumbilical, one suprapubic and one in the lower right quadrant of the abdomen. The appendix is removed using a laparoscopic endostapler enabling a safe and complete appendectomy with the cross stapling line at coecal base. Laparoscopic appendectomy will be performed by a gastrointestinal surgeon with sufficient experience in laparoscopic appendectomies (>20).
Procedure: - Endoscopic appendix biopsies
Appendix biopsies will only be taken when the scope easily slides into the lumen of the appendix (the scope will not be pushed into the appendix lumen)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.