ERAS After Bariatric Surgery in Morbidly Obese

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891822
• Other study ID #: SNU-SLEEVE
• Status: Completed
• Start date: June 2, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2024
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 28, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ERAS
• Obesity

Intervention

Procedure:
• ERAS protocol
E: ERAS protocol C: control

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Universuty, Bundang Hospital	Seongnam-si	Gyonggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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