Clinical trial NCT01974869: Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
Official title: The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Surgery,Crohn's disease,Ulcerative colitis
Lead sponsor: El-Hussuna, Alaa, M.D.
Sponsor class: INDIV
First posted: 2013-11-03
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

Brief summary: 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.

Detailed description: 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:

1. Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
2. Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine

Eligibility criteria: 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

Primary outcomes:
measure: changes in inflammatory cytokines
timeFrame: pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation
Secondary outcomes:
measure: 30 postoperative day complications.
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Slagelse Hospitals
city: Køge
country: Denmark
facility: Køge Hospital
city: Odense
country: Denmark
facility: OUH
city: Århus
country: Denmark
facility: Århus University Hospital
Study officials:
affiliation: Slagelse Hospital
name: Alaa El-Hussuna
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.