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

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ClinicalTrials.gov Identifier: NCT05931458
Recruitment Status : Not yet recruiting
First Posted : July 5, 2023
Last Update Posted : July 5, 2023
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Gaetano Luglio, Federico II University

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Procedure: Appendectomy Drug: Infliximab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
Infliximab
 Drug: Infliximab
Administration of Infliximab (Anti-TNF-a biologic drug)
Experimental: Group 2
Appendectomy
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. Endoscopic remission [ Time Frame: 3 months ]
    Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)

  4. Endoscopic remission [ Time Frame: 12 months ]
    Endoscopic remission at 3 and 12 months (defined as MAYO CU score </ = 1)

  5. 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)

  6. 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)

  7. 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)

  8. 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)


Secondary Outcome Measures :
  1. Clinical Response [ 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).

  2. Clinical Response [ 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).

  3. Failure rate [ 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)

  4. Failure rate [ 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)

  5. Failure rate [ 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)

  6. Complication assessment [ 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.

  7. Complication assessment [ 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.

  8. Histological remission [ 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).


  9. Histological remission [ 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).


  10. Immunohistochemical evaluation [ 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.

  11. Immunohistochemical evaluation [ 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.

  12. Colectomy rate [ Time Frame: 12 months ]
    Evaluation of "Colectomy rate" at 12, 24 and 60 months

  13. Colectomy rate [ Time Frame: 24 months ]
    Evaluation of "Colectomy rate" at 12, 24 and 60 months

  14. Colectomy rate [ Time Frame: 60 months ]
    Evaluation of "Colectomy rate" at 12, 24 and 60 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05931458


Contacts
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Contact: Gaetano Luglio, Prof 00390817462775 gaetano.luglio@unina.it

Sponsors and Collaborators
Federico II University
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Gaetano Luglio, Prof Federico II University
More Information
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Responsible Party: Gaetano Luglio, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT05931458    
Other Study ID Numbers: 340/21
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents