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Clinical Trials/NCT04891822
NCT04891822
Completed
Not Applicable

Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study

Seoul National University Bundang Hospital1 site in 1 country54 target enrollmentJune 2, 2021
ConditionsERASObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ERAS
Sponsor
Seoul National University Bundang Hospital
Enrollment
54
Locations
1
Primary Endpoint
Functional hospital stay
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Recently, the number of bariatric surgery is increasing but ERAS (Enhanced Recovery After Surgery) protocol for bariatric surgery needs revision with evidence. So we investigated usefulness of ERAS protocol for bariatric surgery in morbidly obese patients.

Detailed Description

Patients undergoing elective laparoscopic bariatric surgery are going to be recruited and divided into 2 groups: Group E will receive ERAS protocol, and Group C will receive standard perioperative care. ERAS protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery, TIVA(Total intra-venous anesthesia), TAP(transversus abdominis plane) block and IV-PCA using NSAIDs after surgery, and resumption of oral intake 2 hour after surgery. Conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, IV-PCA using NSAIDs, and resumption oral intake 6 hour after surgery. In both groups, gastric ultrasonography will be used to measure gastric volume before surgery. Functional hospital stay will be recorded from the end of surgery until all discharge criteria had been met. Pain scores will be recorded at 30 minutes, 4 hours, and 24 hours after surgery. Also, nausea and vomiting, time to ambulation, will be documented. After the patients are discharged, their charts are going to be reviewed and their medical expenses will be documented.

Registry
clinicaltrials.gov
Start Date
June 2, 2021
End Date
February 28, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

BON WOOK KOO

assistnat professor

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists grade 1 \~ 3
  • BMI(Body Mass Index) ≥30
  • Scheduled for elective laparoscopic bariatric surgery

Exclusion Criteria

  • American Society of Anesthesiologists grade 4 or 5
  • History of abdominal surgery

Outcomes

Primary Outcomes

Functional hospital stay

Time Frame: from end of surgery, until all discharge criteria had been met (an average of 3 days)

time from the end of surgery until all discharge criteria had been met

Secondary Outcomes

  • Time to ambulation(Time to ambulation (an average of 1 day))
  • Postoperative Pain score(30 minutes, 4 hours, and 24 hours after end of surgery)
  • Postoperative nausea and vomiting(until patient discharge (an average of 3 days))
  • Medical expenses(until patient discharge (an average of 4 days))
  • Rescue drug and dosage(30 minutes, 4 hours, and 24 hours after end of surgery)

Study Sites (1)

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