Enhanced Recovery After SurgeryNCT05649319
ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy
A study testing ERAS protocol in people with Enhanced Recovery After Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2023to 30 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients scheduled to undergo elective laparoscopic distal gastrectomy
- American Society of Anesthesiologists (ASA)physical classification I-II
- ECOG Performance Status Scale 0 or 1
- Willingness and ability to sign an informed consent document
Who cannot join
- Patients with chronic pain
- Gastrectomy with combined resection of other organs
- Patients with history of upper abdominal surgery
- Allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, NSAIDs)
- Medical or psychological disease that can affect the treatment response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study
This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. We hypothesize that our ERAS protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.
Read the detailed description
Adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the ERAS protocol (n=49) or conventional protocol (n=49). The conventional groups receive our current perioperative management. The ERAS groups receive our new ERAS protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. The primary outcome measure was the postoperative quality of recovery evaluated using the Korean version of Quality of recovery-15 at 24, 48, and 72 hours postoperatively. The secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the I-FEED score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the Clavien-Dindo classification during hospitalization, and length of hospital stay.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- ERAS protocol
- Keywords
- Enhanced Recovery After Surgery, Stomach Neoplasms, Gastrectomy, Pain, Postoperative
- Medical subject headings
- Stomach Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
The ERAS protocol involves a pre-admission patient education using audiovisual videos, the reduction of perioperative fasting time with administration of preoperative carbohydrate loading and early resumption of oral feeding after surgery, multimodal postoperative nausea and vomiting prevention, early removal of the nasogastric tube and urinary catheter, and multimodal analgesia to minimize opioid consumption after surgery.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol. Receives: Procedure: ERAS protocol |
| Conventional group | No intervention | Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Quality of recovery-15 during the first 72 hours after surgery
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Measured: postoperative 24, 48, and 72 hours
Secondary outcomes (5)
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Measured: postoperative 24, 48, and 72 hours
Total fentanyl consumption
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Measured: From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative gastrointestinal dysfunction
I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
Measured: postoperative 24, 48, and 72 hours
Recovery time
Postoperative time satisfying the following four criteria: (1) tolerance of soft blended diet (SBD) for 24 h; (2) safe ambulation of 600 m without assistance; (3) Adequate pain control (NRS ≤ 3) with oral non opioid analgesics; and (4) No abnormal physical findings or laboratory test
Measured: Evaluate every hour starting from 9A on the postoperative day 3 up to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start3 Feb 2023
- Primary completion7 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized open-labeled study
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, PhD, Seoul National University Hospital
- Investigators
- Do Joong Park, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649319
- Sponsor's protocol ID
- 2207-206-1346
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2022
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05649319
- Acronym / sponsor ID
- 2207-206-1346
- Conditions
- Enhanced Recovery After Surgery
- Keywords
- Enhanced Recovery After Surgery, Stomach Neoplasms, Gastrectomy, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Dec 2022 (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.
This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. We hypothesize that our ERAS protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.
Detailed description
Adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the ERAS protocol (n=49) or conventional protocol (n=49). The conventional groups receive our current perioperative management. The ERAS groups receive our new ERAS protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. The primary outcome measure was the postoperative quality of recovery evaluated using the Korean version of Quality of recovery-15 at 24, 48, and 72 hours postoperatively. The secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the I-FEED score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the Clavien-Dindo classification during hospitalization, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective randomized open-labeled study
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERAS protocolPerioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol. |
| Conventional group | No intervention | –Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo elective laparoscopic distal gastrectomy
- American Society of Anesthesiologists (ASA)physical classification I-II
- ECOG Performance Status Scale 0 or 1
- Willingness and ability to sign an informed consent document
Key exclusion criteria (5 listed)
- Patients with chronic pain
- Gastrectomy with combined resection of other organs
- Patients with history of upper abdominal surgery
- Allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, NSAIDs)
- Medical or psychological disease that can affect the treatment response
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 protocolThe ERAS protocol involves a pre-admission patient education using audiovisual videos, the reduction of perioperative fasting time with administration of preoperative carbohydrate loading and early resumption of oral feeding after surgery, multimodal postoperative nausea and vomiting prevention, early removal of the nasogastric tube and urinary catheter, and multimodal analgesia to minimize opioid consumption after surgery. | Procedure or surgery | ERAS group |
Primary outcome
Change of the Quality of recovery-15 during the first 72 hours after surgery
Time frame: postoperative 24, 48, and 72 hours
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
5 secondary outcomes
Postoperative pain score
Time frame: postoperative 24, 48, and 72 hours
Total fentanyl consumption
Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative nausea and vomiting
Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative gastrointestinal dysfunction
Time frame: postoperative 24, 48, and 72 hours
Recovery time
Time frame: Evaluate every hour starting from 9A on the postoperative day 3 up to discharge
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 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Enhanced Recovery After Surgery
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
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.
Do Joong Park, MD, PhD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with Enhanced Recovery After Surgery, run by Seoul National University 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 4 inclusion and 5 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 1 Jan 2025. 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?
Change of the Quality of recovery-15 during the first 72 hours after surgery (time frame: postoperative 24, 48, and 72 hours). 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 1 Jan 2025.