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Completed

NCT Number: NCT03456752

Perioperative Dexamethasone on Postoperative Outcome in IBD

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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Key information

Conditions

Inflammatory Bowel Diseases Dexamethasone Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Ileus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
  • ASA I-III

Exclusion criteria

  • Diabetes or hyperglycemia
  • Active gastric ulceration confirmed endoscopically
  • Presence of ongoing infection (such as IAS) or infective chronic diseases
  • Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
  • Emergent surgery
  • Acute angle glaucoma
  • Pregnancy
  • Under 18 years of age
  • Known adverse reaction to dexamethasone
  • Extensive adhesiolysis
  • Carcinogenesis of intestinal tract

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 8mg intravenously prior to induction of anesthesia

normal saline

Drug

Normal saline 1.6ml intravenously prior to induction of anesthesia

Primary outcomes

  1. Prolonged ileus

    Time frame: 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 outcomes

  1. PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery

    Time frame: 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.

  2. Postoperative pain on POD 1, 3, and 5

    Time frame: up to 1 week

    Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)

  3. Postoperative fagitue score on POD 1, 3, and 5

    Time frame: 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)

  4. GI-2 recovery

    Time frame: Day 30

    time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).

  5. Blood WBC levels, preoperative and on postoperative 1,3 and 5

    Time frame: Day 30

    Blood WBC levels, preoperative and on postoperative 1,3 and 5

  6. Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5

    Time frame: Day 30

    Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5

  7. Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5

    Time frame: 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

  8. Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5

    Time frame: Day 30

    Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5

  9. Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5

    Time frame: Day 30

    Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5

  10. Body composition, preoperative and on POD 1

    Time frame: Day 30

    body composition was determined using Bioelectrical impedance analysis (BIA)

  11. Postoperative length of stay

    Time frame: Day 90

    in days

  12. Postoperative morbidity

    Time frame: Day 30

    Documented using comprehensive complication index(CCI)

  13. Postoperative surgical site infections (SSIs)

    Time frame: Day 30

    Including superficial SSIs and deep SSIs.

  14. Overall cost of treatment

    Time frame: up to 1 year

    In Chinese Yuan (CNY)

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 7, 2018
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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