Seoul National Universuty, Bundang Hospital
Seongnam-si, Gyonggido, South Korea
NCT Number: NCT04891822
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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Notify Me19 year–80 year
All sexes
Observational
Seongnam-si, Gyonggido, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E: ERAS protocol C: control
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
Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery
100 mm scale of visual analogue scale (0~100mm)
Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery
Rescue drug and dosage for additional analgesia
Time frame: until patient discharge (an average of 3 days)
The presence or absence of postoperative nausea and vomiting
Time frame: Time to ambulation (an average of 1 day)
Time to ambulation after surgery
Time frame: until patient discharge (an average of 4 days)
Medical expenses during inpatient (Korean won)
Seoul National University Bundang Hospital
Other
Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study
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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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