Ulcerative ColitisADVANCED-UCNCT05931458
AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis
A study testing Appendectomy and Infliximab in people with Ulcerative Colitis, run by Federico II University.
Trial summary
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease (IBD) characterized by a multifactorial etiology, a variable involvement of large bowel, and a relapsing-remitting course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Appendectomy and Infliximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or above
- Patients with a confirmed diagnosis of left-sided UC (extended up to the mid transverse colon)
- Patients with active disease refractory to conventional treatment and candidates for anti- TNF-a treatment
- Patients who have given consent to the surgical procedure
Who cannot join
- Patients under the age of 18
- Lack of diagnostic certainty of Ulcerative Colitis / Crohn's disease diagnostic doubt
- Patients who previously received appendectomy
- Patients who have had previous laparotomic abdominal surgery, which could make the appendectomy more complex
- Patients with Severe Acute Colitis/Toxic Megacolon
- Patients who have not given their consent to the intervention
- Patients who receive a different surgical procedure from appendectomy because of intraoperative complications
- Pregnant patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADVANCED-UC TRIAL: AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis - A Randomized Clinical Trial
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease (IBD) characterized by a multifactorial etiology, a variable involvement of large bowel, and a relapsing-remitting course.
In order to keep the disease in a "quiescent" status and to prevent relapses, a significative percentage of UC patients will remain on long-term drug therapy. However, long-term immunosuppressant therapy is not free of risks and complications: in fact, these therapies have an impact on both healthcare system resources and patients' quality of life; more, there are even concerns regarding the side effects of long-term immunosuppressant therapy.
Read more
Over the past 20 years, a considerable amount of evidence was produced to support the immunomodulatory role of the appendix in the development and course of UC: there is a strong inverse relationship between previous appendectomy and development of the UC. One of the proposed theories to justify this link is that the appendix could act as a reservoir for commensal bacteria that can be secreted into the colon, affecting its microbiome and immunological response; another theory describes the appendix as the "priming site" for the cytokine production and the immunological cascade that may trigger inflammation in colon and rectum.
The idea of this study moves from these assumptions: the investigators aim to evaluate the impact of appendectomy in patients with UC who are candidates to the treatment with biologics (Anti TNF-a), because of conventional therapies failure. To further reduce any ethical problems and significantly lower any surgical morbidity, investigators will restrict the study population to only patients with active left-sided colitis, so that the surgery for appendectomy will take place on a non-inflamed cecum.
By undertaking this study, the investigators hope to a) learn more about the role of appendix and the impact of appendectomy in the clinical history of Ulcerative Colitis; b) demonstrate that laparoscopic appendectomy, a relatively simple surgical procedure that can also be performed in day-surgery with a very low expected complication rate, is a treatment that is superior to biological therapy, avoiding patients starting a chronic, long-lasting therapy, with the consequent risk of immunosuppression, and with possible higher costs for the health system in the long term.
- Conditions
- Ulcerative Colitis
- Being tested
- Appendectomy, Infliximab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Laparoscopic appendectomy is a relatively simple surgical procedure that can be performedby most surgeons, either on an outpatient basis or with a single-night hospital stay. The laparoscopic approach is now the recommended option due to faster recovery times and fewer wound complications.
InfliximabDrug
Administration of Infliximab (Anti-TNF-a biologic drug)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Infliximab Receives: Drug: Infliximab |
| Group 2 | Experimental | Appendectomy Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid Free Clinical Remission
Steroid Free Clinical Remission at 3 and 12 months (defined as Partial Mayo score </=2, with no individual sub-score >1)
Measured: 3 months
Steroid Free Clinical Remission
Steroid Free Clinical Remission at 3 and 12 months (defined as Partial Mayo score </=2, with no individual sub-score >1)
Measured: 12 months
Endoscopic remission
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
Measured: 3 months
Endoscopic remission
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
Measured: 12 months
Assessment of Quality of Life
Assessment of Quality of Life at 3 and 12 months, through the SIBDQ (Short Inflammatory Bowel Disease Questionnaire, ranging from 10, meaning poor quality of life, to 70, meaning optimal quality of life)
Measured: 3 months
Assessment of Quality of Life
Assessment of Quality of Life at 3 and 12 months, through the SIBDQ (Short Inflammatory Bowel Disease Questionnaire, ranging from 10, meaning poor quality of life, to 70, meaning optimal quality of life)
Measured: 12 months
Assessment of Quality of Life
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
Measured: 3 months
Assessment of Quality of Life
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
Measured: 12 months
Secondary outcomes (14)
Clinical Response
Clinical Response at 3 and 12 months (defined as a reduction of the MAYO SCORE of at least 3points). MAYO SCORE ranges from 0 (inactive disease) to 3 (severe disease activity).
Measured: 3 months
Clinical Response
Clinical Response at 3 and 12 months (defined as a reduction of the MAYO SCORE of at least 3points). MAYO SCORE ranges from 0 (inactive disease) to 3 (severe disease activity).
Measured: 12 months
Failure rate
Evaluation of the failure rate at 3, 12 and 24 months (evaluated as the rate of use of the biological or colectomy in the "treatment" group, as the rate of use of a second biological or colectomy in the "control" group)
Measured: 3 months
Failure rate
Evaluation of the failure rate at 3, 12 and 24 months (evaluated as the rate of use of the biological or colectomy in the "treatment" group, as the rate of use of a second biological or colectomy in the "control" group)
Measured: 12 months
Failure rate
Evaluation of the failure rate at 3, 12 and 24 months (evaluated as the rate of use of the biological or colectomy in the "treatment" group, as the rate of use of a second biological or colectomy in the "control" group)
Measured: 24 months
Complication assessment
Complication assessment: Treatment-related serious adverse events will be compared between the two groups. The Dindo-Clavien Classification will be used within 30 days of the procedure in patientsundergoing appendectomy. For patients undergoing biologics, the cumulative rate of treatment- related serious adverse events up to 12 months will be considered. Hospitalization rates will also be assessed as a consequence of adverse events to treatment.
Measured: 30 days
Complication assessment
Complication assessment: Treatment-related serious adverse events will be compared between the two groups. The Dindo-Clavien Classification will be used within 30 days of the procedure in patientsundergoing appendectomy. For patients undergoing biologics, the cumulative rate of treatment- related serious adverse events up to 12 months will be considered. Hospitalization rates will also be assessed as a consequence of adverse events to treatment.
Measured: 12 months
Histological remission
Evaluation of histological remission at 3 and 12 months with the Geboes score (ranging from 0, histological remission, to 22, severe inflammatory injury).
In patients undergoing appendectomy, the appendix will also be histologically evaluated with the same Geboes score in addition to the presence of PARP (peri-appendicular patches).
Measured: 3 months
Histological remission
Evaluation of histological remission at 3 and 12 months with the Geboes score (ranging from 0, histological remission, to 22, severe inflammatory injury).
In patients undergoing appendectomy, the appendix will also be histologically evaluated with the same Geboes score in addition to the presence of PARP (peri-appendicular patches).
Measured: 12 months
Immunohistochemical evaluation
Immunohistochemical evaluation of the IgA / IgG ratio and correlation between the findings onthe appendix and the findings on colonic biopsy at 3 and 12 months.
Measured: 3 months
Immunohistochemical evaluation
Immunohistochemical evaluation of the IgA / IgG ratio and correlation between the findings onthe appendix and the findings on colonic biopsy at 3 and 12 months.
Measured: 12 months
Colectomy rate
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Measured: 12 months
Colectomy rate
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Measured: 24 months
Colectomy rate
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Gaetano Luglio, Federico II University
- Investigators
- Gaetano Luglio, Prof, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931458
- Sponsor's protocol ID
- 340/21
- Acronym
- ADVANCED-UC
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCED-UC TRIAL: AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05931458
- Acronym / sponsor ID
- ADVANCED-UC / 340/21
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Jul 2023 (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.
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease (IBD) characterized by a multifactorial etiology, a variable involvement of large bowel, and a relapsing-remitting course.
In order to keep the disease in a "quiescent" status and to prevent relapses, a significative percentage of UC patients will remain on long-term drug therapy. However, long-term immunosuppressant therapy is not free of risks and complications: in fact, these therapies have an impact on both healthcare system resources and patients' quality of life; more, there are even concerns regarding the side effects of long-term immunosuppressant therapy.
Over the past 20 years, a considerable amount of evidence was produced to support the immunomodulatory role of the appendix in the development and course of UC: there is a strong inverse relationship between previous appendectomy and development of the UC. One of the proposed theories to justify this link is that the appendix could act as a reservoir for commensal bacteria that can be secreted into the colon, affecting its microbiome and immunological response; another theory describes the appendix as the "priming site" for the cytokine production and the immunological cascade that may trigger inflammation in colon and rectum.
The idea of this study moves from these assumptions: the investigators aim to evaluate the impact of appendectomy in patients with UC who are candidates to the treatment with biologics (Anti TNF-a), because of conventional therapies failure. To further reduce any ethical problems and significantly lower any surgical morbidity, investigators will restrict the study population to only patients with active left-sided colitis, so that the surgery for appendectomy will take place on a non-inflamed cecum.
By undertaking this study, the investigators hope to a) learn more about the role of appendix and the impact of appendectomy in the clinical history of Ulcerative Colitis; b) demonstrate that laparoscopic appendectomy, a relatively simple surgical procedure that can also be performed in day-surgery with a very low expected complication rate, is a treatment that is superior to biological therapy, avoiding patients starting a chronic, long-lasting therapy, with the consequent risk of immunosuppression, and with possible higher costs for the health system in the long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: InfliximabInfliximab |
| Group 2 | Experimental | Procedure: AppendectomyAppendectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or above
- Patients with a confirmed diagnosis of left-sided UC (extended up to the mid transverse colon)
- Patients with active disease refractory to conventional treatment and candidates for anti- TNF-a treatment
- Patients who have given consent to the surgical procedure
Key exclusion criteria (8 listed)
- Patients under the age of 18
- Lack of diagnostic certainty of Ulcerative Colitis / Crohn's disease diagnostic doubt
- Patients who previously received appendectomy
- Patients who have had previous laparotomic abdominal surgery, which could make the appendectomy more complex
- Patients with Severe Acute Colitis/Toxic Megacolon
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 |
|---|---|---|
| AppendectomyLaparoscopic appendectomy is a relatively simple surgical procedure that can be performedby most surgeons, either on an outpatient basis or with a single-night hospital stay. The laparoscopic approach is now the recommended option due to faster recovery times and fewer wound complications. | Procedure or surgery | Group 2 |
| InfliximabAdministration of Infliximab (Anti-TNF-a biologic drug) | Drug | Group 1 |
Primary outcome
Steroid Free Clinical Remission
Time frame: 3 months
Steroid Free Clinical Remission at 3 and 12 months (defined as Partial Mayo score </=2, with no individual sub-score >1)
Steroid Free Clinical Remission
Time frame: 12 months
Steroid Free Clinical Remission at 3 and 12 months (defined as Partial Mayo score </=2, with no individual sub-score >1)
Endoscopic remission
Time frame: 3 months
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
Endoscopic remission
Time frame: 12 months
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
Assessment of Quality of Life
Time frame: 3 months
Assessment of Quality of Life at 3 and 12 months, through the SIBDQ (Short Inflammatory Bowel Disease Questionnaire, ranging from 10, meaning poor quality of life, to 70, meaning optimal quality of life)
Assessment of Quality of Life
Time frame: 12 months
Assessment of Quality of Life at 3 and 12 months, through the SIBDQ (Short Inflammatory Bowel Disease Questionnaire, ranging from 10, meaning poor quality of life, to 70, meaning optimal quality of life)
Assessment of Quality of Life
Time frame: 3 months
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
Assessment of Quality of Life
Time frame: 12 months
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
14 secondary outcomes
Clinical Response
Time frame: 3 months
Clinical Response
Time frame: 12 months
Failure rate
Time frame: 3 months
Failure rate
Time frame: 12 months
Failure rate
Time frame: 24 months
Complication assessment
Time frame: 30 days
Complication assessment
Time frame: 12 months
Histological remission
Time frame: 3 months
Histological remission
Time frame: 12 months
Immunohistochemical evaluation
Time frame: 3 months
Immunohistochemical evaluation
Time frame: 12 months
Colectomy rate
Time frame: 12 months
Colectomy rate
Time frame: 24 months
Colectomy rate
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
Gaetano Luglio, Prof principal investigator
Federico II University
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy and Infliximab in people with Ulcerative Colitis, run by Federico II University.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Luglio, Prof (00390817462775, gaetano.luglio@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid Free Clinical Remission (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2023.