Clinical trial NCT04891822: ERAS After Bariatric Surgery in Morbidly Obese
Official title: Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Obesity
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly obese patients undergoing elective laparoscopic bariatric surgery at Seoul National Bundang Hospital

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.

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

Primary outcomes:
measure: Functional hospital stay
timeFrame: from end of surgery, until all discharge criteria had been met (an average of 3 days)
Secondary outcomes:
measure: Postoperative Pain score
timeFrame: 30 minutes, 4 hours, and 24 hours after end of surgery
measure: Rescue drug and dosage
timeFrame: 30 minutes, 4 hours, and 24 hours after end of surgery
measure: Postoperative nausea and vomiting
timeFrame: until patient discharge (an average of 3 days)
measure: Time to ambulation
timeFrame: Time to ambulation (an average of 1 day)
measure: Medical expenses
timeFrame: until patient discharge (an average of 4 days)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Universuty, Bundang Hospital
state: Gyonggido
Study officials:
affiliation: SNUBH
name: Bon Wook Koo, MD
role: STUDY_DIRECTOR
References: