AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis

Официальное название

ADVANCED-UC TRIAL: AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis - A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Процедура Appendectomy
  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.
• Препарат Infliximab
  Administration of Infliximab (Anti-TNF-a biologic drug)

Первичные конечные точки

• Steroid Free Clinical Remission [Срок оценки: 3 months]
• Steroid Free Clinical Remission [Срок оценки: 12 months]
• Endoscopic remission [Срок оценки: 3 months]
• Endoscopic remission [Срок оценки: 12 months]
• Assessment of Quality of Life [Срок оценки: 3 months]
• Assessment of Quality of Life [Срок оценки: 12 months]
• Assessment of Quality of Life [Срок оценки: 3 months]
• Assessment of Quality of Life [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Clinical Response [Срок оценки: 3 months]
• Clinical Response [Срок оценки: 12 months]
• Failure rate [Срок оценки: 3 months]
• Failure rate [Срок оценки: 12 months]
• Failure rate [Срок оценки: 24 months]
• Complication assessment [Срок оценки: 30 days]
• Complication assessment [Срок оценки: 12 months]
• Histological remission [Срок оценки: 3 months]
• Histological remission [Срок оценки: 12 months]
• Immunohistochemical evaluation [Срок оценки: 3 months]
• Immunohistochemical evaluation [Срок оценки: 12 months]
• Colectomy rate [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05931458 · 340/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗