Back to resultsPerioperative Dexamethasone on Postoperative Outcome in IBD
Primary Purpose
Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnancy
- Under 18 years of age
- Known adverse reaction to dexamethasone
- Extensive adhesiolysis
- Carcinogenesis of intestinal tract
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Control
Arm Description
Dexamethasone 8mg intravenously prior to anesthesia induction
Normal Saline 1.6ml intravenously prior to anesthesia induction
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Postoperative pain on POD 1, 3, and 5
Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)
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)
GI-2 recovery
time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
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
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
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Body composition, preoperative and on POD 1
body composition was determined using Bioelectrical impedance analysis (BIA)
Postoperative length of stay
in days
Postoperative morbidity
Documented using comprehensive complication index(CCI)
Postoperative surgical site infections (SSIs)
Including superficial SSIs and deep SSIs.
Overall cost of treatment
In Chinese Yuan (CNY)
Full Information
NCT ID
NCT03456752
First Posted
February 22, 2018
Last Updated
February 8, 2021
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03456752
Brief Title
Perioperative Dexamethasone on Postoperative Outcome in IBD
Official Title
The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
January 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus, Postoperative Complications
Keywords
Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 8mg intravenously prior to anesthesia induction
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal Saline 1.6ml intravenously prior to anesthesia induction
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 8mg intravenously prior to induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline 1.6ml intravenously prior to induction of anesthesia
Primary Outcome Measure Information:
Title
Prolonged ileus
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery
Description
the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.
Time Frame
24hr
Title
Postoperative pain on POD 1, 3, and 5
Description
Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)
Time Frame
up to 1 week
Title
Postoperative fagitue score on POD 1, 3, and 5
Description
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)
Time Frame
up to 1 week
Title
GI-2 recovery
Description
time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Time Frame
Day 30
Title
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Description
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Time Frame
Day 30
Title
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Description
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Time Frame
Day 30
Title
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5
Description
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
Time Frame
Day 30
Title
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Description
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Time Frame
Day 30
Title
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Description
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Time Frame
Day 30
Title
Body composition, preoperative and on POD 1
Description
body composition was determined using Bioelectrical impedance analysis (BIA)
Time Frame
Day 30
Title
Postoperative length of stay
Description
in days
Time Frame
Day 90
Title
Postoperative morbidity
Description
Documented using comprehensive complication index(CCI)
Time Frame
Day 30
Title
Postoperative surgical site infections (SSIs)
Description
Including superficial SSIs and deep SSIs.
Time Frame
Day 30
Title
Overall cost of treatment
Description
In Chinese Yuan (CNY)
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnancy
Under 18 years of age
Known adverse reaction to dexamethasone
Extensive adhesiolysis
Carcinogenesis of intestinal tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33749741
Citation
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.
Results Reference
derived
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Perioperative Dexamethasone on Postoperative Outcome in IBD
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