Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative Dexamethasone on Postoperative Outcome in IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456752
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Dexamethasone Postoperative Ileus Postoperative Complications Drug: Dexamethasone Drug: Normal saline Phase 2

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dexamethasone
Dexamethasone 8mg intravenously prior to anesthesia induction
 Drug: Dexamethasone
Dexamethasone 8mg intravenously prior to induction of anesthesia
Placebo Comparator: Control
Normal Saline 1.6ml intravenously prior to anesthesia induction
 Drug: Normal saline
Normal saline 1.6ml intravenously prior to induction of anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery [ Time Frame: 24hr ]
    the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.

  2. Postoperative pain on POD 1, 3, and 5 [ Time Frame: up to 1 week ]
    Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)

  3. Postoperative fagitue score on POD 1, 3, and 5 [ Time Frame: up to 1 week ]
    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)

  4. GI-2 recovery [ Time Frame: Day 30 ]
    time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).

  5. Blood WBC levels, preoperative and on postoperative 1,3 and 5 [ Time Frame: Day 30 ]
    Blood WBC levels, preoperative and on postoperative 1,3 and 5

  6. Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5 [ Time Frame: Day 30 ]
    Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5

  7. Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5 [ Time Frame: Day 30 ]
    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

  8. Serum Interleukin-6 (IL-6) 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

  9. Serum procalcitonin (PCT) 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

  10. Body composition, preoperative and on POD 1 [ Time Frame: Day 30 ]
    body composition was determined using Bioelectrical impedance analysis (BIA)

  11. Postoperative length of stay [ Time Frame: Day 90 ]
    in days

  12. Postoperative morbidity [ Time Frame: Day 30 ]
    Documented using comprehensive complication index(CCI)

  13. Postoperative surgical site infections (SSIs) [ Time Frame: Day 30 ]
    Including superficial SSIs and deep SSIs.

  14. Overall cost of treatment [ Time Frame: up to 1 year ]
    In Chinese Yuan (CNY)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
  2. ASA I-III

Exclusion Criteria:

  1. Diabetes or hyperglycemia
  2. Active gastric ulceration confirmed endoscopically
  3. Presence of ongoing infection (such as IAS) or infective chronic diseases
  4. Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
  5. Emergent surgery
  6. Acute angle glaucoma
  7. Pregnancy
  8. Under 18 years of age
  9. Known adverse reaction to dexamethasone
  10. Extensive adhesiolysis
  11. Carcinogenesis of intestinal tract
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456752


Locations
Layout table for location information
China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Layout table for investigator information
Principal Investigator: Jianfeng Gong, MD Jinling Hospital, China
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jianfeng Gong, Associate Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03456752    
Other Study ID Numbers: DEX-IBD
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Inflammatory Bowel Diseases
Glucocorticosteroids
Postoperative Outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Postoperative Complications
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pathologic Processes
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents