ERAS After Bariatric Surgery in Morbidly Obese

NCT ID: NCT04891822

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2022-02-28

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.

Conditions

ERAS; Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ERAS protocol

Intervention Type: PROCEDURE

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.

No interventions assigned to this group

Interventions

ERAS protocol

E: ERAS protocol C: control

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

BON WOOK KOO

assistnat professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bon Wook Koo, MD

Role: STUDY_DIRECTOR

SNUBH

Locations

Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

Countries

South Korea

Other Identifiers

SNU-SLEEVE

Identifier Type: -

Identifier Source: org_study_id