Inflammatory Bowel DiseasesNCT01974869
Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
An observational study of Inflammatory Bowel Diseases, run by El-Hussuna, Alaa, M.D. at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Anti-tumor necrosis factor alpha agents
- How many people
- 47 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2014to Aug 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
Who may be able to join
- Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
Who cannot join
- No patients will be excluded
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Århus University Hospital
Aarhus
Slagelse Hospitals
Copenhagen
Køge Hospital
Køge
OUH
Odense
About this study
Official title: The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery
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.
Read the 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:
- Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
- Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Anti-tumor necrosis factor alpha agents
- Keywords
- Surgery,Crohn's disease,Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-tumor necrosis factor alpha agentsDrug
Also called Biologics
Treatment with biologics
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel diseases-1 | Treatment with anti-tumor necrosis factor alpha agents Receives: Drug: Anti-tumor necrosis factor alpha agents | |
| Inflammatory bowel diseases-2 | Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in inflammatory cytokines
Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10
Measured: pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation
Secondary outcomes (1)
30 postoperative day complications.
Secondary outcome measure is 30 postoperative day complications.
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- El-Hussuna, Alaa, M.D.
- Responsible party
- Principal investigator, Alaa El-Hussuna, El-Hussuna, Alaa, M.D.
- Investigators
- Alaa El-Hussuna, Principal investigator, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974869
- Sponsor's protocol ID
- a-TNF
- Status last verified
- Feb 2017
- First submitted
- 23 Oct 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: To be planned
Publications
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.
PubMed 30390672
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01974869
- Acronym / sponsor ID
- a-TNF
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Surgery,Crohn's disease,Ulcerative colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- El-Hussuna, Alaa, M.D.
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
- Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel diseases-1 | – | Drug: Anti-tumor necrosis factor alpha agentsTreatment with anti-tumor necrosis factor alpha agents |
| Inflammatory bowel diseases-2 | – | –Controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
Key inclusion criteria (1 listed)
- Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
Key exclusion criteria (1 listed)
- No patients will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-tumor necrosis factor alpha agentsAlso: BiologicsTreatment with biologics | Drug | Inflammatory bowel diseases-1 |
Primary outcome
changes in inflammatory cytokines
Time frame: pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation
Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10
1 secondary outcome
30 postoperative day complications.
Time frame: 30 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 30390672El-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.
- Individual participant dataSharing planned: Yes. To be planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El-Hussuna principal investigator
Slagelse Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by El-Hussuna, Alaa, M.D. at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in inflammatory cytokines (time frame: pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.