Perioperative Dexamethasone on Postoperative Outcome in IBD

February 8, 2021 updated by: Jianfeng Gong, Jinling Hospital, China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24hr
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)
up to 1 week
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)
up to 1 week
GI-2 recovery
Time Frame: Day 30
time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Day 30
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
Day 30
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
Day 30
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
Day 30
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
Day 30
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
Day 30
Body composition, preoperative and on POD 1
Time Frame: Day 30
body composition was determined using Bioelectrical impedance analysis (BIA)
Day 30
Postoperative length of stay
Time Frame: Day 90
in days
Day 90
Postoperative morbidity
Time Frame: Day 30
Documented using comprehensive complication index(CCI)
Day 30
Postoperative surgical site infections (SSIs)
Time Frame: Day 30
Including superficial SSIs and deep SSIs.
Day 30
Overall cost of treatment
Time Frame: up to 1 year
In Chinese Yuan (CNY)
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEX-IBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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