NCT03456752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

February 22, 2018

Last Update Submit

February 8, 2021

Conditions

Inflammatory Bowel DiseasesDexamethasonePostoperative IleusPostoperative Complications

Keywords

Inflammatory Bowel DiseasesGlucocorticosteroidsPostoperative Outcome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 30

Secondary Outcomes (14)

  • PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery

    24hr

  • Postoperative pain on POD 1, 3, and 5

    up to 1 week

  • Postoperative fagitue score on POD 1, 3, and 5

    up to 1 week

  • GI-2 recovery

    Day 30

  • Blood WBC levels, preoperative and on postoperative 1,3 and 5

    Day 30

  • +9 more secondary outcomes

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 8mg intravenously prior to anesthesia induction

Drug: Dexamethasone

Control

PLACEBO COMPARATOR

Normal Saline 1.6ml intravenously prior to anesthesia induction

Drug: Normal saline

Interventions

DexamethasoneDRUG

Dexamethasone 8mg intravenously prior to induction of anesthesia

Dexamethasone
Normal salineDRUG

Normal saline 1.6ml intravenously prior to induction of anesthesia

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

  • 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.

    PMID: 33749741DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesPostoperative Complications

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jianfeng Gong, MD

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 7, 2018

Study Start

June 1, 2018

Primary Completion

December 13, 2019

Study Completion

January 13, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)