AnesthesiologyNCT06209983
The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery
A study testing ERAS and Conventional care in people with Anesthesiology and General Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesiology, General Surgery
- What is being tested?
- ERAS and Conventional care
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pathological confirmed as gastric adenocarcinoma;
- Gastric cancer patients who will undergo subtotal gastrectomy.
Who cannot join
- Advanced gastric cancer with gastric outlet obstruction;
- Epidural catheter placement contraindicated or inexecutable;
- Have other cancers that have received chemotherapy or radiation therapy;
- Coagulation abnormalities;
- Pregnancy;
- Severe dysfunction of major organs (e.g., heart failure, chronic obstructive pulmonary disease, liver cirrhosis, end-stage renal disease)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery.
Read the detailed description
Gastric cancer is 7th common malignant disease in Taiwan, accounting for 3000 new cases per year. The main treatment of gastric cancer is radical gastrectomy and lymph nodes dissection, which is associated with 13.0~46 % of surgical morbidities. To minimize the surgical morbidities and enhance patients' recovery, perioperative management is mandatory. Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator, and staff from units that care for the surgical patient. The main elements of ERAS include carbohydrate loading before surgery, minimally invasive approaches, balanced management of intravenous fluids, multimodal pain management, early mobilization, and early oral feeding, etc. Some prospective studies have shown its effectiveness in reduce surgical morbidity and hospital stay in colorectal surgery. In Taiwan, there was only limited report to study the use of ERAS in gastric cancer surgery. The investigators would like to integrate these perioperative interventions into the ERAS program, and test its effectiveness in gastric cancer patients undergoing radical gastrectomy at NTUH.
- Conditions
- Anesthesiology, General Surgery
- Being tested
- ERAS, Conventional care
- Keywords
- ERAS, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
- Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation.
- Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia.
- Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting.
Conventional careProcedure or surgery
- Preoperative preparation: overnight fasting preparation, bowel preparation.
- Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine).
- Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters.
| Study group | Role | What they receive |
|---|---|---|
| Arm E | Experimental | 1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation.
2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia.
3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting. Receives: Procedure: ERAS |
| Arm H | Placebo comparator | 1. Preoperative preparation: overnight fasting preparation, bowel preparation.
2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine).
3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters. Receives: Procedure: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
When patient discharge.
Measured: From date of admission until the date of discharge, assessed up to 2 weeks.
Secondary outcomes (1)
Complication rates
The complication rates means if there are any complications occur.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start5 Dec 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209983
- Sponsor's protocol ID
- 201809008RINC
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT06209983
- Acronym / sponsor ID
- 201809008RINC
- Conditions
- Anesthesiology, General Surgery
- Keywords
- ERAS, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jan 2024 (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.
The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery.
Detailed description
Gastric cancer is 7th common malignant disease in Taiwan, accounting for 3000 new cases per year. The main treatment of gastric cancer is radical gastrectomy and lymph nodes dissection, which is associated with 13.0~46 % of surgical morbidities. To minimize the surgical morbidities and enhance patients' recovery, perioperative management is mandatory. Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator, and staff from units that care for the surgical patient. The main elements of ERAS include carbohydrate loading before surgery, minimally invasive approaches, balanced management of intravenous fluids, multimodal pain management, early mobilization, and early oral feeding, etc. Some prospective studies have shown its effectiveness in reduce surgical morbidity and hospital stay in colorectal surgery. In Taiwan, there was only limited report to study the use of ERAS in gastric cancer surgery. The investigators would like to integrate these perioperative interventions into the ERAS program, and test its effectiveness in gastric cancer patients undergoing radical gastrectomy at NTUH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm E | Experimental | Procedure: ERAS1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation. 2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia. 3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting. |
| Arm H | Placebo comparator | Procedure: Conventional care1. Preoperative preparation: overnight fasting preparation, bowel preparation. 2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine). 3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathological confirmed as gastric adenocarcinoma;
- Gastric cancer patients who will undergo subtotal gastrectomy.
Key exclusion criteria (6 listed)
- Advanced gastric cancer with gastric outlet obstruction;
- Epidural catheter placement contraindicated or inexecutable;
- Have other cancers that have received chemotherapy or radiation therapy;
- Coagulation abnormalities;
- Pregnancy;
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 |
|---|---|---|
| ERAS1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation. 2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia. 3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting. | Procedure or surgery | Arm E |
| Conventional care1. Preoperative preparation: overnight fasting preparation, bowel preparation. 2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine). 3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters. | Procedure or surgery | Arm H |
Primary outcome
Length of hospital stay
Time frame: From date of admission until the date of discharge, assessed up to 2 weeks.
When patient discharge.
1 secondary outcome
Complication rates
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Conventional care in people with Anesthesiology and General Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Feb 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Length of hospital stay (time frame: From date of admission until the date of discharge, assessed up to 2 weeks.). 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 28 Feb 2024.