Perioperative Dexamethasone on Postoperative Outcome in IBD

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: Completed
• Conditions: Postoperative Complications; Inflammatory Bowel Diseases; Dexamethasone; Postoperative Ileus
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal saline

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: Interventional
• Enrollment (Actual): 302
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery	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	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	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 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	Blood WBC levels, preoperative and on postoperative 1,3 and 5	Day 30
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5	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	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	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	Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5	Day 30
Body composition, preoperative and on POD 1	body composition was determined using Bioelectrical impedance analysis (BIA)	Day 30
Postoperative length of stay	in days	Day 90
Postoperative morbidity	Documented using comprehensive complication index(CCI)	Day 30
Postoperative surgical site infections (SSIs)	Including superficial SSIs and deep SSIs.	Day 30
Overall cost of treatment	In Chinese Yuan (CNY)	up to 1 year

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Diseases; Glucocorticosteroids; Postoperative Outcome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Postoperative Complications; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID 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