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OpenTrials
Completed

NCT Number: NCT04891822

ERAS After Bariatric Surgery in Morbidly Obese

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS protocol

Procedure

E: ERAS protocol C: control

Primary outcomes

  1. Functional hospital stay

    Time frame: from 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 outcomes

  1. Postoperative Pain score

    Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery

    100 mm scale of visual analogue scale (0~100mm)

  2. Rescue drug and dosage

    Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery

    Rescue drug and dosage for additional analgesia

  3. Postoperative nausea and vomiting

    Time frame: until patient discharge (an average of 3 days)

    The presence or absence of postoperative nausea and vomiting

  4. Time to ambulation

    Time frame: Time to ambulation (an average of 1 day)

    Time to ambulation after surgery

  5. Medical expenses

    Time frame: until patient discharge (an average of 4 days)

    Medical expenses during inpatient (Korean won)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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