Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

NCT01974869 | Completed DMC

• 1 other identifier: a-TNF
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 4

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Surgery,Crohn's disease,Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 30 postoperative day complications.

  30 days after operation

Study Arms (2)

Inflammatory bowel diseases-1

Treatment with anti-tumor necrosis factor alpha agents

Drug: Anti-tumor necrosis factor alpha agents

Inflammatory bowel diseases-2

Controls

Interventions

Anti-tumor necrosis factor alpha agents DRUG

Treatment with biologics

Also known as: Biologics

Inflammatory bowel diseases-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

You may qualify if:

• Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

You may not qualify if:

• No patients will be excluded

Sponsors & Collaborators

• El-Hussuna, Alaa, M.D.: lead

Study Sites (4)

Århus University Hospital

Aarhus, Denmark

Location

Slagelse Hospitals

Copenhagen, Denmark

Location

Køge Hospital

Køge, Denmark

Location

OUH

Odense, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30390672 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Alaa El-Hussuna

  Slagelse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 4, 2013
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (4)