ERAS After Bariatric Surgery in Morbidly Obese

NCT04891822 | Completed

• 1 other identifier: SNU-SLEEVE
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

ERAS; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Pain score

  30 minutes, 4 hours, and 24 hours after end of surgery

• Rescue drug and dosage

  30 minutes, 4 hours, and 24 hours after end of surgery

• Postoperative nausea and vomiting

  until patient discharge (an average of 3 days)

• Time to ambulation

  Time to ambulation (an average of 1 day)

• Medical expenses

  until patient discharge (an average of 4 days)

Study Arms (2)

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

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.

Interventions

ERAS protocol PROCEDURE

E: ERAS protocol C: control

E (ERAS protocol)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bon Wook Koo, MD

  SNUBH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistnat professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 18, 2021
• Study Start: June 2, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 28, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

KR (1)