Clinical trial · Observational
Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor Necrosis Factor-α agents are antibodies directed against a key cytokine in the process angiogenesis and collagen synthesis. It is not known whether they intervene with surgical stress response increasing the rate of postoperative complications. Method: Un-blinded prospective, non-interventional cohort single centre study including all the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery. Immunological and endocrinological parameters will measured in blood samples taken from these patients before and after surgery. Power calculations showed that 17 patients in each arm are needed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-tumor necrosis factor alpha agents | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Inflammatory bowel diseases-1
- description
- Treatment with anti-tumor necrosis factor alpha agents
- interventionNames
- Drug: Anti-tumor necrosis factor alpha agents
- label
- Inflammatory bowel diseases-2
- description
- Controls
Primary outcomes (1)
- measure
- changes in inflammatory cytokines
- timeFrame
- pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation
- description
- Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open) Exclusion Criteria: No patients will be excluded
References
Publications (1)
- DERIVEDEl-Hussuna A, Qvist N, Zangenberg MS, Langkilde A, Siersma V, Hjort S, Gogenur I. No effect of anti-TNF-alpha agents on the surgical stress response in patients with inflammatory bowel disease undergoing bowel resections: a prospective multi-center pilot study. BMC Surg. 2018 Nov 3;18(1):91. doi: 10.1186/s12893-018-0425-0. PMID 30390672