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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.
The baseline patient characteristics will be evaluated based on pilot tested data extraction sheets. The assessment will include demographics, clinical data as well as laboratory work up. The Charlson morbidity index, will be used to assess co-morbidity, the Nutritional risk score (NRS) to assess nutrition status and the Harvey-Bradshaw index (HBI) to evaluate the activity of Crohn's disease. The duration of surgical procedure, along with the amount of blood transfused, will be recorded in all patients.
Laboratory variables
The following variables will be assessed based on previous evidence about their role in surgical stress response:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory bowel diseases-1 | Treatment with anti-tumor necrosis factor alpha agents |
| |
| Inflammatory bowel diseases-2 | Controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-tumor necrosis factor alpha agents | Drug | Treatment with biologics |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in inflammatory cytokines | Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10 | pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| 30 postoperative day complications. | Secondary outcome measure is 30 postoperative day complications. | 30 days after operation |
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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
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Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
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| Name | Affiliation | Role |
|---|---|---|
| Alaa El-Hussuna | Slagelse Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Århus University Hospital | Aarhus | Denmark | ||||
| Slagelse Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30390672 | Derived | El-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. |
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To be planned
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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Blood samples
| Copenhagen |
| Denmark |
| Køge Hospital | Køge | Denmark |
| OUH | Odense | Denmark |