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

NCT05931458 | Not Yet Recruiting

• 1 other identifier: 340/21
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (8)

• 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)

  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)

  12 months

• Endoscopic remission

  Endoscopic remission at 3 and 12 months (defined as MAYO CU score \</ = 1)

  3 months

• Endoscopic remission

  Endoscopic remission at 3 and 12 months (defined as MAYO CU score \</ = 1)

  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)

  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)

  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)

  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)

  12 months

Secondary Outcomes (14)

• Clinical Response

  3 months

• Clinical Response

  12 months

• Failure rate

  3 months

• Failure rate

  12 months

• Failure rate

  24 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Infliximab

Drug: Infliximab

Group 2

EXPERIMENTAL

Appendectomy

Procedure: Appendectomy

Interventions

Appendectomy PROCEDURE

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.

Group 2

Infliximab DRUG

Administration of Infliximab (Anti-TNF-a biologic drug)

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead
• Crohn's and Colitis Foundation: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Appendectomy; Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gaetano Luglio, Prof

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Luglio, Prof

CONTACT

00390817462775; gaetano.luglio@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 5, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the end of the study