Perioperative Dexamethasone on Postoperative Outcome in IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-01-13

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Inflammatory Bowel Diseases Dexamethasone Postoperative Ileus Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone

Dexamethasone 8mg intravenously prior to anesthesia induction

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 8mg intravenously prior to induction of anesthesia

Control

Normal Saline 1.6ml intravenously prior to anesthesia induction

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline 1.6ml intravenously prior to induction of anesthesia

Interventions

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Dexamethasone

Dexamethasone 8mg intravenously prior to induction of anesthesia

Intervention Type DRUG

Normal saline

Normal saline 1.6ml intravenously prior to induction of anesthesia

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No