Perioperative Dexamethasone on Postoperative Outcome in IBD

Phase 2

Completed

• Conditions: Dexamethasone; Inflammatory Bowel Diseases; Postoperative Complications; Postoperative Ileus
• Interventions: Drug: Normal saline; Drug: Dexamethasone

• Registration Number: NCT03456752
• Lead Sponsor: Jinling Hospital, China

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.

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 Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Study Start: 2018-06-01
• Primary Completion: 2019-12-13
• Study Completion: 2020-01-13
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	Normal Saline 1.6ml intravenously prior to anesthesia induction
Dexamethasone	Dexamethasone	Dexamethasone 8mg intravenously prior to anesthesia induction

Primary Outcome Measures

Name	Time	Method
Prolonged ileus	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative length of stay	Day 90	in days
Postoperative pain on POD 1, 3, and 5	up to 1 week	Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery	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.
Blood WBC levels, preoperative and on postoperative 1,3 and 5	Day 30	Blood WBC levels, preoperative and on postoperative 1,3 and 5
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5	Day 30	Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5	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
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5	Day 30	Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Postoperative fagitue score on POD 1, 3, and 5	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)
GI-2 recovery	Day 30	time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5	Day 30	Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Body composition, preoperative and on POD 1	Day 30	body composition was determined using Bioelectrical impedance analysis (BIA)
Postoperative morbidity	Day 30	Documented using comprehensive complication index(CCI)
Postoperative surgical site infections (SSIs)	Day 30	Including superficial SSIs and deep SSIs.
Overall cost of treatment	up to 1 year	In Chinese Yuan (CNY)

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China