NCT Number: NCT05931458
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Administration of Infliximab (Anti-TNF-a biologic drug)
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)
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)
Time frame: 3 months
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
Time frame: 12 months
Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)
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)
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)
Time frame: 3 months
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
Time frame: 12 months
Assessment of Quality of Life at 3 and 12 months, through the SF-36 questionnaire (Short-form 36)
Time frame: 3 months
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).
Time frame: 12 months
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).
Time frame: 3 months
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)
Time frame: 12 months
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)
Time frame: 24 months
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)
Time frame: 30 days
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.
Time frame: 12 months
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.
Time frame: 3 months
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).
Time frame: 12 months
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).
Time frame: 3 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Time frame: 24 months
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Time frame: 60 months
Evaluation of "Colectomy rate" at 12, 24 and 60 months
Contact information is provided by the study sponsor or research team.
Federico II University
Other
ADVANCED-UC TRIAL: AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis - A Randomized Clinical Trial
Acronym: ADVANCED-UC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07619547
Colitis, Colitis, Ulcerative
Bethesda, Maryland, United States
View Trial DetailsNCT07250815
Colitis, Colitis, Ulcerative
Cambridge, Massachusetts, United States
View Trial DetailsNCT07665294
Colitis, Colitis, Ulcerative
New York, United States
View Trial DetailsNCT07697456
Colitis, Colitis, Ulcerative
Lakeland, Florida, United States
View Trial Details