Colitis, UlcerativeCOSTANCT03912714
COlonic Salvage by Therapeutic Appendectomy.
A study testing Laparoscopic appendectomy and Endoscopic appendix biopsies in people with Colitis, Ulcerative, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 procto-colectomy with ileal J-pouch anastomosis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Laparoscopic appendectomy and Endoscopic appendix biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Aug 2018to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 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 biological treatment
- Obtained written informed consent
- Age 16 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
- Obtained written informed consent
Who cannot join
- Prior appendectomy or other abdominal surgery by laparotomy precluding safe appendectomy
- Suspicion of Crohn's disease.
- Toxic megacolon or severe acute colitis necessitating clinical admission.
- History or suspicion of colonic dysplasia or malignancy.
- Required daily oral prednisone dose exceeding 20 milligrams.
- Patients with active extra-intestinal infections, liver or kidney failure, mayor lung and heart co-morbidity.
Show all 9Show fewer
- Insufficient command of Dutch or cognitively unable to complete Dutch questionnaires.
- Prior appendectomy.
- Suspicion of Crohn's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Appendectomy in Ulcerative Colitis Patients With Active Disease: COlonic Salvage by Therapeutic Appendectomy
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 procto-colectomy 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 compared to usual care. The second objective is to evaluate if it is possible to predict response to appendectomy based on preoperative radiological or endoscopic findings by comparing results to histological characteristics in the resection specimen.
Read more
Study design: The design of the study is a multicentre prospective cohort study including patients with active UC despite standard step-up treatment including optimized biological treatment. Patients failing standard step-up medical treatment (including biologicals), that are discussed in the multidisciplinary meeting to be counselled for a JAK-inhibitor (e.g. tofacitinib, filgotinib) or restorative proctcolectomy with ileal-j pouch anastomosis, will be counselled for appendectomy as an alternative treatment option. All patients will undergo colonoscopy before the start of a new treatment according to current guidelines. Biopsies will be taken to histologically confirm ongoing inflammation. Cecal biopsies will be used to correlate histological findings to response to appendectomy. Patients will undergo assessment of the appendix by ultrasound before surgery. All patients will be followed according to study protocol.
Study population: All patients of 16 years and older, with established diagnosis of UC and ongoing disease activity despite standard step-up treatment including optimized biological treatment that are counselled for medication switch to a small molecule JAK-inhibitor or colectomy, will also be counselled for experimental appendectomy. Patients not interested in appendectomy will be asked for consent to collect data according to study protocol and represent the control group.
Group size calculations are based on an improvement in remission rates from 17% in the second line medical group to 40% in the appendectomy group. With a power of 80%, a 2-sided alpha of 0.05, and accounting for 10% loss to follow-up, a total of 67 patients are required in each group.
Intervention: A laparoscopic appendectomy will be performed in day care setting using a laparoscopic endostapler including the cecal base.
Comparison: Usual care consists of small molecule JAK-inhibitor (e.g. tofacitinib, filgotinib) or surgical treatment by restorative proctocolectomy with ileal J-pouch anastomosis.
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.
Read the detailed description
The study is designed as a prospective observational cohort study including patients with active ulcerative colitis despite standard step-up treatment including optimized biological therapy. Sixty-seven consecutive patients who are refractory to medical treatment will be recruited to evaluate the effect of the appendectomy on the disease course. Patients not interested in appendectomy will be asked for consent to collect all data according to study protocol and represent the control group. These patients either receive switch in medical treatment to the small molecule JAK-inhibitor (e.g. tofacitinib, filgotinib or upadacitinib) or a procto-colectomy.
All eligible patients will be extensively counselled about these three treatment options at the outpatient clinics by a gastroenterologist and/or surgeon. Patients who failed small molecules can be counselled for appendectomy if not done so when initially counselled for treatment with small molecules. Patients with presumed therapy-refractory inflammation will undergo ileocolonoscopy, which is part of standard daily practice. 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. Patients will also undergo preoperative ultrasound to assess clinical characteristics of the appendix preoperatively.
After inclusion, a laparoscopic appendectomy will be performed within 9 weeks. Patients will be followed 3, 6, 12 and 30 months after laparoscopic appendectomy to assess the patients' clinical condition and the non-invasive Mayo score. According to standard practice evaluating therapy change, an endoscopy including biopsies of colon and cecal base 12 months after appendectomy will be performed 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) at inclusion and at 3, 6, 12 and 30 months follow-up, alongside the MYMOP at inclusion and 12 months follow up via email or a telemedicine application (MyIBDcoach).
The preoperative ultrasound findings and endoscopic cecal biopsies will be used to analyse 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 cecal biopsies will be taken to use as a reference control group
- Conditions
- Colitis, Ulcerative
- Being tested
- Laparoscopic appendectomy, Endoscopic appendix biopsies
- Keywords
- Appendectomy, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
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).
Endoscopic appendix biopsiesProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic appendectomy | Experimental | Laparoscopic appendectomy in therapy refractory ulcerative colitis patients after pre-operative endoscopic biopsies of the appendix Receives: Procedure: Laparoscopic appendectomy; Procedure: Endoscopic appendix biopsies |
| Non-active UC | Active comparator | Patients with non-active ulcerative colitis planned for surveillance colonoscopy will have additional endoscopic appendix biopsies to evaluate the histological characteristics of the appendix. Receives: Procedure: Endoscopic appendix biopsies |
| Healthy control | Active comparator | '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. Receives: Procedure: Endoscopic appendix biopsies |
| JAK-inhibitor | Active comparator | JAK-inhibitor in therapy-refractory ulcerative colitis patients Receives: Procedure: Endoscopic appendix biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Steroid-free remission rate (Total Mayo Score ≤2, with no individual sub-score exceeding 1 point) 12 months after appendectomy without switch of therapy.
Measured: 12 months
Secondary outcomes (8)
Reduction of medical therapy including corticosteroids
Downscaling of medical therapy including corticosteroids (number of patients that stop medication).
Measured: Every 3 months, up to 12 months
Disease activity, as measured with the full Mayo score
Using this 12-point scoring system, disease activity is evaluated based on stool frequency, rectal bleeding, the physician's global assessment, and endoscopic appearance. Each subscale is ranging from 0-3 and higher values represent worse outcomes. The full Mayo score is computed by the sum of the four subscores.
Measured: 6 and 12 months
Failure
Defined as colectomy, switch of biological treatment, (re)start of corticosteroids or start of trial medication after a minimum of 1 month postoperative.
Measured: Every 3 months, up to 12 months
Health related quality of life (EQ-5D)
This questionnaire is a simple, generic instrument for describing and valuing health related quality of life. It includes 5 items (mobility, personal care, daily activities, pain, and anxiety/ depression) that are answered on a 3-point scale ranging from no problems (level 1) to extreme problems (level 3).
Measured: 3, 6 and 12 months
Disease specific quality of life (IBDQ)
A disease-specific questionnaire that measures quality of life in 4 domains (bowel symptoms, systemic symptoms, social function, and emotional function). The IBDQ consists of 32 questions which are rated on a scale from 1 to 7, resulting in a total score ranging from 32 to 224 and a higher score represents a better quality of life.
Measured: 3, 6 and 12 months
Time to remission
Time between inclusion and remission
Measured: Every 3 months, up to 12 months
Pathological analysis of resection specimen to determine histological characteristics according to the Geboes score, predictive of response .
Geboes score less than 3: (grade 0-5: architectural changes, increase of chronic inflammatory infiltrate, increase of eosinophils in the lamina propria, increase of neutrophils in the lamina propria, involvement of neutrophils in the epithelium (cryptitis), crypt destruction, and erosion or ulcerations)
Measured: Baseline
Global quality of life (EORTC-QLQ-C30-QL)
This sub questionnaire contains the 2 items of the global quality of life dimension of the EORTC-QLQ-C30 questionnaire. It includes 30 questions, and answers are ranging from no problems (1 point) to extreme problems (4 points).
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start24 Aug 2018
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Principal investigator, Willem A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Christianne Buskens, MD, PhD, Principal investigator, Amsterdam Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912714
- Sponsor's protocol ID
- 2018_058
- Acronym
- COSTA
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2018
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visser E, Reijntjes MA, Heuthorst L, Stellingwerf ME, West R, van Dongen K, Crolla RMPH, van Dieren S, van der Bilt JDW, Bemelman WA, D'Haens GR, Buskens CJ; COSTA Study Group. Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):190-203. doi: 10.1016/S2468-1253(25)00291-2. Epub 2026 Jan 6.
PubMed 41512889
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Appendectomy in Ulcerative Colitis Patients With Active Disease: COlonic Salvage by Therapeutic Appendectomy
- ClinicalTrials.gov ID
- NCT03912714
- Acronym / sponsor ID
- COSTA / 2018_058
- Conditions
- Colitis, Ulcerative
- Keywords
- Appendectomy, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 procto-colectomy 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 compared to usual care. The second objective is to evaluate if it is possible to predict response to appendectomy based on preoperative radiological or endoscopic findings by comparing results to histological characteristics in the resection specimen.
Study design: The design of the study is a multicentre prospective cohort study including patients with active UC despite standard step-up treatment including optimized biological treatment. Patients failing standard step-up medical treatment (including biologicals), that are discussed in the multidisciplinary meeting to be counselled for a JAK-inhibitor (e.g. tofacitinib, filgotinib) or restorative proctcolectomy with ileal-j pouch anastomosis, will be counselled for appendectomy as an alternative treatment option. All patients will undergo colonoscopy before the start of a new treatment according to current guidelines. Biopsies will be taken to histologically confirm ongoing inflammation. Cecal biopsies will be used to correlate histological findings to response to appendectomy. Patients will undergo assessment of the appendix by ultrasound before surgery. All patients will be followed according to study protocol.
Study population: All patients of 16 years and older, with established diagnosis of UC and ongoing disease activity despite standard step-up treatment including optimized biological treatment that are counselled for medication switch to a small molecule JAK-inhibitor or colectomy, will also be counselled for experimental appendectomy. Patients not interested in appendectomy will be asked for consent to collect data according to study protocol and represent the control group.
Group size calculations are based on an improvement in remission rates from 17% in the second line medical group to 40% in the appendectomy group. With a power of 80%, a 2-sided alpha of 0.05, and accounting for 10% loss to follow-up, a total of 67 patients are required in each group.
Intervention: A laparoscopic appendectomy will be performed in day care setting using a laparoscopic endostapler including the cecal base.
Comparison: Usual care consists of small molecule JAK-inhibitor (e.g. tofacitinib, filgotinib) or surgical treatment by restorative proctocolectomy with ileal J-pouch anastomosis.
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.
Detailed description
The study is designed as a prospective observational cohort study including patients with active ulcerative colitis despite standard step-up treatment including optimized biological therapy. Sixty-seven consecutive patients who are refractory to medical treatment will be recruited to evaluate the effect of the appendectomy on the disease course. Patients not interested in appendectomy will be asked for consent to collect all data according to study protocol and represent the control group. These patients either receive switch in medical treatment to the small molecule JAK-inhibitor (e.g. tofacitinib, filgotinib or upadacitinib) or a procto-colectomy.
All eligible patients will be extensively counselled about these three treatment options at the outpatient clinics by a gastroenterologist and/or surgeon. Patients who failed small molecules can be counselled for appendectomy if not done so when initially counselled for treatment with small molecules. Patients with presumed therapy-refractory inflammation will undergo ileocolonoscopy, which is part of standard daily practice. 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. Patients will also undergo preoperative ultrasound to assess clinical characteristics of the appendix preoperatively.
After inclusion, a laparoscopic appendectomy will be performed within 9 weeks. Patients will be followed 3, 6, 12 and 30 months after laparoscopic appendectomy to assess the patients' clinical condition and the non-invasive Mayo score. According to standard practice evaluating therapy change, an endoscopy including biopsies of colon and cecal base 12 months after appendectomy will be performed 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) at inclusion and at 3, 6, 12 and 30 months follow-up, alongside the MYMOP at inclusion and 12 months follow up via email or a telemedicine application (MyIBDcoach).
The preoperative ultrasound findings and endoscopic cecal biopsies will be used to analyse 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 cecal biopsies will be taken to use as a reference control group
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic appendectomy | Experimental | Procedure: Laparoscopic appendectomy, Procedure: Endoscopic appendix biopsiesLaparoscopic appendectomy in therapy refractory ulcerative colitis patients after pre-operative endoscopic biopsies of the appendix |
| Non-active UC | Active comparator | Procedure: Endoscopic appendix biopsiesPatients with non-active ulcerative colitis planned for surveillance colonoscopy will have additional endoscopic appendix biopsies to evaluate the histological characteristics of the appendix. |
| Healthy control | Active comparator | Procedure: Endoscopic appendix biopsies'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. |
| JAK-inhibitor | Active comparator | Procedure: Endoscopic appendix biopsiesJAK-inhibitor in therapy-refractory ulcerative colitis patients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 16 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 biological treatment
- Obtained written informed consent
- Age 16 years and older
Key exclusion criteria (9 listed)
- Prior appendectomy or other abdominal surgery by laparotomy precluding safe appendectomy
- Suspicion of Crohn's disease.
- Toxic megacolon or severe acute colitis necessitating clinical admission.
- History or suspicion of colonic dysplasia or malignancy.
- Required daily oral prednisone dose exceeding 20 milligrams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomySurgery 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 or surgery | Laparoscopic appendectomy |
| Endoscopic appendix biopsiesAppendix 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) | Procedure or surgery | Healthy control, JAK-inhibitor, Laparoscopic appendectomy, Non-active UC |
Primary outcome
Remission rate
Time frame: 12 months
Steroid-free remission rate (Total Mayo Score ≤2, with no individual sub-score exceeding 1 point) 12 months after appendectomy without switch of therapy.
8 secondary outcomes
Reduction of medical therapy including corticosteroids
Time frame: Every 3 months, up to 12 months
Disease activity, as measured with the full Mayo score
Time frame: 6 and 12 months
Failure
Time frame: Every 3 months, up to 12 months
Health related quality of life (EQ-5D)
Time frame: 3, 6 and 12 months
Disease specific quality of life (IBDQ)
Time frame: 3, 6 and 12 months
Time to remission
Time frame: Every 3 months, up to 12 months
Pathological analysis of resection specimen to determine histological characteristics according to the Geboes score, predictive of response .
Time frame: Baseline
Global quality of life (EORTC-QLQ-C30-QL)
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 41512889Visser E, Reijntjes MA, Heuthorst L, Stellingwerf ME, West R, van Dongen K, Crolla RMPH, van Dieren S, van der Bilt JDW, Bemelman WA, D'Haens GR, Buskens CJ; COSTA Study Group. Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):190-203. doi: 10.1016/S2468-1253(25)00291-2. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christianne Buskens, MD, PhD principal investigator
Amsterdam Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic appendectomy and Endoscopic appendix biopsies in people with Colitis, Ulcerative, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03912714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.