Perioperative Dexamethasone on Postoperative Outcome in IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456752
• Other study ID #: DEX-IBD
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: February 2021
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: January 13, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexamethasone
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Postoperative Complications
• Postoperative Ileus

Intervention

Drug:
• Dexamethasone
Dexamethasone 8mg intravenously prior to induction of anesthesia
• Normal saline
Normal saline 1.6ml intravenously prior to induction of anesthesia

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	GI-2 recovery	time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).	Day 30
Secondary	Blood WBC levels, preoperative and on postoperative 1,3 and 5	Blood WBC levels, preoperative and on postoperative 1,3 and 5	Day 30
Secondary	Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5	Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5	Day 30
Secondary	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
Secondary	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
Secondary	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
Secondary	Body composition, preoperative and on POD 1	body composition was determined using Bioelectrical impedance analysis (BIA)	Day 30
Secondary	Postoperative length of stay	in days	Day 90
Secondary	Postoperative morbidity	Documented using comprehensive complication index(CCI)	Day 30
Secondary	Postoperative surgical site infections (SSIs)	Including superficial SSIs and deep SSIs.	Day 30
Secondary	Overall cost of treatment	In Chinese Yuan (CNY)	up to 1 year