Perioperative Dexamethasone on Postoperative Outcome in IBD

Sponsor
Jinling Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT03456752
Collaborator
(none)
302
Enrollment
1
Location
2
Arms
19.4
Actual Duration (Months)
15.6
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
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

Study Type:
Interventional
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 :
Jun 1, 2018
Actual Primary Completion Date :
Dec 13, 2019
Actual Study Completion Date :
Jan 13, 2020

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Prolonged ileus [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 [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 [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 [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 [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 [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 [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 [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 [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 [Day 30]

    Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5

  10. Body composition, preoperative and on POD 1 [Day 30]

    body composition was determined using Bioelectrical impedance analysis (BIA)

  11. Postoperative length of stay [Day 90]

    in days

  12. Postoperative morbidity [Day 30]

    Documented using comprehensive complication index(CCI)

  13. Postoperative surgical site infections (SSIs) [Day 30]

    Including superficial SSIs and deep SSIs.

  14. Overall cost of treatment [up to 1 year]

    In Chinese Yuan (CNY)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing UniversityNanjingJiangsuChina210000

Sponsors and Collaborators

  • Jinling Hospital, China

Investigators

  • Principal Investigator: Jianfeng Gong, MD, Jinling Hospital, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianfeng Gong, Associate Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT03456752
Other Study ID Numbers:
  • DEX-IBD
First Posted:
Mar 7, 2018
Last Update Posted:
Feb 11, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Associate Professor, Jinling Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2021