ERAS After Bariatric Surgery in Morbidly Obese

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; ERAS
• Intervention / Treatment: Procedure: ERAS protocol

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyonggido
    • Seongnam-si, Gyonggido, Korea, Republic of
      • Seoul National Universuty, Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients undergoing elective laparoscopic bariatric surgery at Seoul National Bundang Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
E (ERAS protocol); receive ERAS protocol 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery TIVA(Total intra-venous anesthesia) TAP(transversus abdominis plane) block IV-PCA using NSAIDs after surgery Resuming oral intake 2 hours after surgery.	Procedure: ERAS protocol; E: ERAS protocol C: control
C (Control); receive standard perioperative care 8 hours of fasting before surgery Inhalation anesthesia IV-PCA using NSAIDs Resuming oral intake 6 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional hospital stay	time from the end of surgery until all discharge criteria had been met	from end of surgery, until all discharge criteria had been met (an average of 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain score	100 mm scale of visual analogue scale (0~100mm)	30 minutes, 4 hours, and 24 hours after end of surgery
Rescue drug and dosage	Rescue drug and dosage for additional analgesia	30 minutes, 4 hours, and 24 hours after end of surgery
Postoperative nausea and vomiting	The presence or absence of postoperative nausea and vomiting	until patient discharge (an average of 3 days)
Time to ambulation	Time to ambulation after surgery	Time to ambulation (an average of 1 day)
Medical expenses	Medical expenses during inpatient (Korean won)	until patient discharge (an average of 4 days)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Director: Bon Wook Koo, MD, SNUBH

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SNU-SLEEVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No