ERASNCT04891822
ERAS After Bariatric Surgery in Morbidly Obese
An observational study of ERAS and Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients undergoing elective laparoscopic bariatric surgery at Seoul National Bundang Hospital
Who may be able to join
- American Society of Anesthesiologists grade 1 ~ 3
- BMI(Body Mass Index) ≥30
- Scheduled for elective laparoscopic bariatric surgery
Who cannot join
- American Society of Anesthesiologists grade 4 or 5
- History of abdominal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Universuty, Bundang Hospital
Seongnam-si, Gyonggido
About this study
Official title: Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study
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.
Read the 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.
- Being tested
- ERAS protocol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
E: ERAS protocol C: control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ERAS protocol | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional hospital stay
time from the end of surgery until all discharge criteria had been met
Measured: from end of surgery, until all discharge criteria had been met (an average of 3 days)
Secondary outcomes (5)
Postoperative Pain score
100 mm scale of visual analogue scale (0~100mm)
Measured: 30 minutes, 4 hours, and 24 hours after end of surgery
Rescue drug and dosage
Rescue drug and dosage for additional analgesia
Measured: 30 minutes, 4 hours, and 24 hours after end of surgery
Postoperative nausea and vomiting
The presence or absence of postoperative nausea and vomiting
Measured: until patient discharge (an average of 3 days)
Time to ambulation
Time to ambulation after surgery
Measured: Time to ambulation (an average of 1 day)
Medical expenses
Medical expenses during inpatient (Korean won)
Measured: until patient discharge (an average of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start2 Jun 2021
- Primary completion24 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- Bon Wook Koo, MD, Study director, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891822
- Sponsor's protocol ID
- SNU-SLEEVE
- Status last verified
- Jan 2024
- First submitted
- 23 Apr 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04891822
- Acronym / sponsor ID
- SNU-SLEEVE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E (ERAS protocol) | – | Procedure: ERAS protocolreceive 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. |
| 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients undergoing elective laparoscopic bariatric surgery at Seoul National Bundang Hospital
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists grade 1 ~ 3
- BMI(Body Mass Index) ≥30
- Scheduled for elective laparoscopic bariatric surgery
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists grade 4 or 5
- History of abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolE: ERAS protocol C: control | Procedure or surgery | E (ERAS protocol) |
Primary outcome
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
5 secondary outcomes
Postoperative Pain score
Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery
Rescue drug and dosage
Time frame: 30 minutes, 4 hours, and 24 hours after end of surgery
Postoperative nausea and vomiting
Time frame: until patient discharge (an average of 3 days)
Time to ambulation
Time frame: Time to ambulation (an average of 1 day)
Medical expenses
Time frame: until patient discharge (an average of 4 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon Wook Koo, MD study director
SNUBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ERAS and Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional hospital stay (time frame: from end of surgery, until all discharge criteria had been met (an average of 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.