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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04891822
Enrollment
54
Registered
2021-05-18
Start date
2021-06-02
Completion date
2022-02-28
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERAS, Obesity

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.

Interventions

PROCEDUREERAS protocol

E: ERAS protocol C: control

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional hospital stayfrom 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

MeasureTime frameDescription
Medical expensesuntil patient discharge (an average of 4 days)Medical expenses during inpatient (Korean won)
Postoperative Pain score30 minutes, 4 hours, and 24 hours after end of surgery100 mm scale of visual analogue scale (0\ 100mm)
Rescue drug and dosage30 minutes, 4 hours, and 24 hours after end of surgeryRescue drug and dosage for additional analgesia
Postoperative nausea and vomitinguntil patient discharge (an average of 3 days)The presence or absence of postoperative nausea and vomiting
Time to ambulationTime to ambulation (an average of 1 day)Time to ambulation after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026