AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis
Not applicable · Testing Appendectomy and Infliximab · Sites not listed yet · Federico II University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Appendectomy (a procedure) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 94 participants are expected to take part.
- Start date: 2023-07-01 (planned).
- Main results expected around 2024-07-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Steroid Free Clinical Remission (3 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Federico II University |
| Collaborators | Crohn's and Colitis Foundation |
| Enrollment | 94 (estimated) |
| Start date | 2023-07-01 |
| Primary completion (est.) | 2024-07-01 |
| First posted | 2023-07-05 |
| Last updated | 2023-07-05 |
| 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 |
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. - Infliximab (Drug)
Administration of Infliximab (Anti-TNF-a biologic drug)
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.