Gastric CancerPhase 2ERASNCT01938313
Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy
A Phase 2 study testing ERAS perioperative cares and Conventional perioperative cares in people with Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ERAS perioperative cares and Conventional perioperative cares
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Apr 2016
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- American Society of Anesthesiologists (ASA) scores < 3
- 20 < Age < 80
- Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
- Informed consent
- No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
- No systemic inflammatory disease
Who cannot join
- Emergency operation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Geynggi
About this study
Official title: Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.
Read the detailed description
There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
- Conditions
- Gastric Cancer
- Being tested
- ERAS perioperative cares, Conventional perioperative cares
- Keywords
- gastric cancer, ERAS (early recovery after surgery), fast track, laparoscopic gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS perioperative caresProcedure or surgery
- Patient's preoperative counseling \& education before surgery
- No Bowel preparation
- Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
- Fluid restriction \& Management by pulse contour analysis or transesophageal doppler
- Early mobilization
- Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
- Epidural patient controlled analgesics (no opioids analgesics)
- Postoperative Nausea Active Control
- Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
- Perioperative High content Oxygen therapy
- No drain insertion
- No Levin tube
- Patients will be discharged at POD#4 if there's no problem.
Conventional perioperative caresProcedure or surgery
- No Patient's preoperative counseling \& education before surgery
- Bowel preparation
- No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
- Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
- Conventional Mobilization
- Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
- IV PCA
- Postoperative Nausea Control if needed
- No Thromboembolism prophylaxis
- No or Low Content Oxygen therapy
- Routine drain insertion
- Levin tube insertion if needed
| Study group | Role | What they receive |
|---|---|---|
| ERAS perioperative cares | Active comparator | Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols. Receives: Procedure: ERAS perioperative cares |
| Conventional perioperative cares | Active comparator | Patents will be managed by our hospital's critical pathways. Receives: Procedure: Conventional perioperative cares |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovering Rate
- Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
- Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
- Safe ambulation (ambulation of 600m without assistance)
- Afebrile status without major complications (fever defined as body temperature greater than 37.5)
- Above total 4 criteria should be satisfied for the evaluation of complete recovery.
Measured: 4 days after surgery
Secondary outcomes (7)
Postoperative length of hospital stay
Measured: up to 4 weeks after surgery
Time to tolerance of a full diet
Measured: up to 1 month after surgery
Time to first bowel motion Time to first bowel motion
Measured: up to 7 days after surgery
Complications during the admissionTime to first bowel motion
Measured: up to 30 days after surgery
Readmission rate
Measured: up to 30 days after surgery
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days
Measured: up to 3 days after surgery
Quality of life
European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month
Measured: up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Ho Kim, Seoul National University Bundang Hospital
- Investigators
- Hyung-Ho Kim, M.D., Ph.D., Principal investigator, Department of Surgery, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938313
- Sponsor's protocol ID
- SNUBH-ERAS-GC-PII
- Acronym
- ERAS
- Status last verified
- Jan 2017
- First submitted
- 15 Jul 2012
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, Kim HH. Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.
PubMed 30051365
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
- ClinicalTrials.gov ID
- NCT01938313
- Acronym / sponsor ID
- ERAS / SNUBH-ERAS-GC-PII
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, ERAS (early recovery after surgery), fast track, laparoscopic gastrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Sep 2013 (estimated)
- 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.
Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.
Detailed description
There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS perioperative cares | Active comparator | Procedure: ERAS perioperative caresPatients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols. |
| Conventional perioperative cares | Active comparator | Procedure: Conventional perioperative caresPatents will be managed by our hospital's critical pathways. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elective surgery
- American Society of Anesthesiologists (ASA) scores < 3
- 20 < Age < 80
- Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
- Informed consent
Key exclusion criteria (1 listed)
- Emergency operation
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 perioperative cares1. Patient's preoperative counseling \& education before surgery 2. No Bowel preparation 3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) 7. Epidural patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) 10. Perioperative High content Oxygen therapy 11. No drain insertion 12. No Levin tube 13. Patients will be discharged at POD#4 if there's no problem. | Procedure or surgery | ERAS perioperative cares |
| Conventional perioperative cares1. No Patient's preoperative counseling \& education before surgery 2. Bowel preparation 3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) 5. Conventional Mobilization 6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) 7. IV PCA 8. Postoperative Nausea Control if needed 9. No Thromboembolism prophylaxis 10. No or Low Content Oxygen therapy 11. Routine drain insertion 12. Levin tube insertion if needed | Procedure or surgery | Conventional perioperative cares |
Primary outcome
Recovering Rate
Time frame: 4 days after surgery
1. Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting 2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) 3. Safe ambulation (ambulation of 600m without assistance) 4. Afebrile status without major complications (fever defined as body temperature greater than 37.5) * Above total 4 criteria should be satisfied for the evaluation of complete recovery.
7 secondary outcomes
Postoperative length of hospital stay
Time frame: up to 4 weeks after surgery
Time to tolerance of a full diet
Time frame: up to 1 month after surgery
Time to first bowel motion Time to first bowel motion
Time frame: up to 7 days after surgery
Complications during the admissionTime to first bowel motion
Time frame: up to 30 days after surgery
Readmission rate
Time frame: up to 30 days after surgery
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days
Time frame: up to 3 days after surgery
Quality of life
Time frame: up to 1 month after surgery
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 5 Jan 2017.
- Derived from this study: PubMed 30051365Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, Kim HH. Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
RecruitingPhase 1
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 1
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Colorectal Cancer, Non-Small Cell Lung Cancer
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
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.
Hyung-Ho Kim, M.D., Ph.D. principal investigator
Department of Surgery, SNUBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ERAS perioperative cares and Conventional perioperative cares in people with Gastric Cancer, 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 7 inclusion and 1 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 5 Jan 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recovering Rate (time frame: 4 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938313, which also lists 1 linked publication.
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 5 Jan 2017.