Gastric CancerNCT03079596
ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy
A 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 68 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
- 1 Oct 2019to 31 Dec 2022
- 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 20 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- American Society of Anesthesiologists (ASA) scores < 3
- Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal 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
- conversion to open
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyung-Ho Kim, M.D. Ph.D., +82-31-787-7095, hhkim@snubh.org
Ju-Hee Lee, M.D., +82-31-787-7090, leejuhee79@gmail.com
About this study
Official title: Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Total Gastrectomy and Proximal 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 total gastrectomy and proximal 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), laparoscopic total 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 total 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.
Tolerance of diet for 24 hours
Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
Measured: 4 days after surgery
Analgesic-free
Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Measured: 4 days after surgery
Safe ambulation
Safe ambulation (ambulation of 600m without assistance)
Measured: 4 days after surgery
Afebrile status without major complications
Afebrile status without major complications (fever defined as body temperature greater than 37.5)
Measured: 4 days after surgery
Secondary outcomes (3)
Postoperative length of hospital stay
Postoperative length of hospital stay
Measured: up to 4 weeks after surgery
Time to tolerance of a full diet
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Hoon Ahn, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079596
- Sponsor's protocol ID
- B-1608-357-006
- Status last verified
- Aug 2021
- First submitted
- 9 Mar 2017
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. 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 Total Gastrectomy and Proximal Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study)
- ClinicalTrials.gov ID
- NCT03079596
- Acronym / sponsor ID
- B-1608-357-006
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, ERAS (early recovery after surgery), laparoscopic total gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Mar 2017 (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.
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 total gastrectomy and proximal 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 total 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 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective surgery
- American Society of Anesthesiologists (ASA) scores < 3
- Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy
- Informed consent
- No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
Key exclusion criteria (1 listed)
- conversion to open
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 caresPatient'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. | Procedure or surgery | ERAS perioperative cares |
| Conventional perioperative caresNo 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 | Procedure or surgery | Conventional perioperative cares |
Primary outcome
Tolerance of diet for 24 hours
Time frame: 4 days after surgery
Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
Analgesic-free
Time frame: 4 days after surgery
Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Safe ambulation
Time frame: 4 days after surgery
Safe ambulation (ambulation of 600m without assistance)
Afebrile status without major complications
Time frame: 4 days after surgery
Afebrile status without major complications (fever defined as body temperature greater than 37.5)
3 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 frame: up to 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
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 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 6 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: status not confirmed, as of the sponsor's last update on 11 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of diet for 24 hours (time frame: 4 days after surgery). The study lists 4 primary outcomes in all. 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 11 Aug 2021.