Inflammatory Bowel DiseasesPhase 2NCT03456752
Perioperative Dexamethasone on Postoperative Outcome in IBD
A Phase 2 study testing Dexamethasone and Normal saline in people with Inflammatory Bowel Diseases and Dexamethasone, run by Jinling Hospital, China at 1 site in China.
Trial summary
The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal resection for inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus
- What is being tested?
- Dexamethasone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 13 Jan 2020
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
- ASA I-III
Who cannot join
- Diabetes or hyperglycemia
- Active gastric ulceration confirmed endoscopically
- Presence of ongoing infection (such as IAS) or infective chronic diseases
- Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
- Emergent surgery
- Acute angle glaucoma
Show all 11Show fewer
- Pregnancy
- Under 18 years of age
- Known adverse reaction to dexamethasone
- Extensive adhesiolysis
- Carcinogenesis of intestinal tract
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
About this study
Official title: The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal resection for inflammatory bowel disease.
Read the detailed description
Patients undergoing surgery for IBD is associated with increased inflammatory response and incidence of prolonged ileus after surgery compared to other colorectal disease such as CRC. Previous studies have revealed that preoperative administration of glucocorticosteroids(GCs) decreased complications and length of postoperative length of hospital after major abdominal surgery as a likely consequence of attenuating the postsurgical inflammatory response. Also, a single dose of GCs did not increase complications in colorectal surgery. The aim of the study is to examine whether a single dose of dexamethasone prior to induction of anesthesia could promote the recovery of patients and reduce the incidence of prolonged ileus after surgery for IBD
- Conditions
- Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus, Postoperative Complications
- Being tested
- Dexamethasone, Normal saline
- Keywords
- Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome
- Medical subject headings
- Inflammatory Bowel Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 8mg intravenously prior to induction of anesthesia
Normal salineDrug
Normal saline 1.6ml intravenously prior to induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8mg intravenously prior to anesthesia induction Receives: Drug: Dexamethasone |
| Control | Placebo comparator | Normal Saline 1.6ml intravenously prior to anesthesia induction Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged ileus
Prolonged POI was defined as if two or more of the following five criteria are met on day 4 postoperatively: nausea or vomiting; inability to tolerate an oral diet over last 24 h; absence of flatus over last 24 h; abdominal distension; and radiologic confirmation.
Measured: Day 30
Secondary outcomes (14)
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery
the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.
Measured: 24hr
Postoperative pain on POD 1, 3, and 5
Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)
Measured: up to 1 week
Postoperative fagitue score on POD 1, 3, and 5
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4). The FACIT-IT score is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Measured: up to 1 week
GI-2 recovery
time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Measured: Day 30
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Measured: Day 30
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Measured: Day 30
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and
Measured: Day 30
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Measured: Day 30
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Measured: Day 30
Body composition, preoperative and on POD 1
body composition was determined using Bioelectrical impedance analysis (BIA)
Measured: Day 30
Postoperative length of stay
in days
Measured: Day 90
Postoperative morbidity
Documented using comprehensive complication index(CCI)
Measured: Day 30
Postoperative surgical site infections (SSIs)
Including superficial SSIs and deep SSIs.
Measured: Day 30
Overall cost of treatment
In Chinese Yuan (CNY)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Jun 2018
- Primary completion13 Dec 2019
- Study completion13 Jan 2020
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Jianfeng Gong, MD, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456752
- Sponsor's protocol ID
- DEX-IBD
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang T, Xu Y, Yao Y, Jin L, Liu H, Zhou Y, Gu L, Ji Q, Zhu W, Gong J. Randomized Controlled Trial: Perioperative Dexamethasone Reduces Excessive Postoperative Inflammatory Response and Ileus After Surgery for Inflammatory Bowel Disease. Inflamm Bowel Dis. 2021 Oct 20;27(11):1756-1765. doi: 10.1093/ibd/izab065.
PubMed 33749741
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
- ClinicalTrials.gov ID
- NCT03456752
- Acronym / sponsor ID
- DEX-IBD
- Conditions
- Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus, Postoperative Complications
- Keywords
- Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 7 Mar 2018 (actual)
- 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.
The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal resection for inflammatory bowel disease.
Detailed description
Patients undergoing surgery for IBD is associated with increased inflammatory response and incidence of prolonged ileus after surgery compared to other colorectal disease such as CRC. Previous studies have revealed that preoperative administration of glucocorticosteroids(GCs) decreased complications and length of postoperative length of hospital after major abdominal surgery as a likely consequence of attenuating the postsurgical inflammatory response. Also, a single dose of GCs did not increase complications in colorectal surgery. The aim of the study is to examine whether a single dose of dexamethasone prior to induction of anesthesia could promote the recovery of patients and reduce the incidence of prolonged ileus after surgery for IBD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone 8mg intravenously prior to anesthesia induction |
| Control | Placebo comparator | Drug: Normal salineNormal Saline 1.6ml intravenously prior to anesthesia induction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
- ASA I-III
Key exclusion criteria (11 listed)
- Diabetes or hyperglycemia
- Active gastric ulceration confirmed endoscopically
- Presence of ongoing infection (such as IAS) or infective chronic diseases
- Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
- Emergent surgery
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 |
|---|---|---|
| DexamethasoneDexamethasone 8mg intravenously prior to induction of anesthesia | Drug | Dexamethasone |
| Normal salineNormal saline 1.6ml intravenously prior to induction of anesthesia | Drug | Control |
Primary outcome
Prolonged ileus
Time frame: Day 30
Prolonged POI was defined as if two or more of the following five criteria are met on day 4 postoperatively: nausea or vomiting; inability to tolerate an oral diet over last 24 h; absence of flatus over last 24 h; abdominal distension; and radiologic confirmation.
14 secondary outcomes
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery
Time frame: 24hr
Postoperative pain on POD 1, 3, and 5
Time frame: up to 1 week
Postoperative fagitue score on POD 1, 3, and 5
Time frame: up to 1 week
GI-2 recovery
Time frame: Day 30
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Time frame: Day 30
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Time frame: Day 30
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5
Time frame: Day 30
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Time frame: Day 30
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Time frame: Day 30
Body composition, preoperative and on POD 1
Time frame: Day 30
Postoperative length of stay
Time frame: Day 90
Postoperative morbidity
Time frame: Day 30
Postoperative surgical site infections (SSIs)
Time frame: Day 30
Overall cost of treatment
Time frame: up to 1 year
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 11 Feb 2021.
- Derived from this study: PubMed 33749741Zhang T, Xu Y, Yao Y, Jin L, Liu H, Zhou Y, Gu L, Ji Q, Zhu W, Gong J. Randomized Controlled Trial: Perioperative Dexamethasone Reduces Excessive Postoperative Inflammatory Response and Ileus After Surgery for Inflammatory Bowel Disease. Inflamm Bowel Dis. 2021 Oct 20;27(11):1756-1765. doi: 10.1093/ibd/izab065.
- Individual participant dataSharing planned: No
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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.
Jianfeng Gong, MD principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Normal saline in people with Inflammatory Bowel Diseases and Dexamethasone, run by Jinling Hospital, China at 1 site in China.
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 2 inclusion and 11 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prolonged ileus (time frame: Day 30). 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 NCT03456752, 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 11 Feb 2021.