Clinical trial NCT03456752: Perioperative Dexamethasone on Postoperative Outcome in IBD
Official title: The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Dexamethasone
Postoperative Ileus
Postoperative Complications
Keywords: Inflammatory Bowel Diseases
Glucocorticosteroids
Postoperative Outcome
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Prolonged ileus
timeFrame: Day 30
Secondary outcomes:
measure: PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery
timeFrame: 24hr
measure: Postoperative pain on POD 1, 3, and 5
timeFrame: up to 1 week
measure: Postoperative fagitue score on POD 1, 3, and 5
timeFrame: up to 1 week
measure: GI-2 recovery
timeFrame: Day 30
measure: Blood WBC levels, preoperative and on postoperative 1,3 and 5
timeFrame: Day 30
measure: Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
timeFrame: Day 30
measure: Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5
timeFrame: Day 30
measure: Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
timeFrame: Day 30
measure: Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
timeFrame: Day 30
measure: Body composition, preoperative and on POD 1
timeFrame: Day 30
measure: Postoperative length of stay
timeFrame: Day 90
measure: Postoperative morbidity
timeFrame: Day 30
measure: Postoperative surgical site infections (SSIs)
timeFrame: Day 30
measure: Overall cost of treatment
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Jianfeng Gong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.