Liver DiseasesNCT02533193
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
A study testing ERAS perioperative cares and Conventional perioperative cares in people with Liver Diseases, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- 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
- 126 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Aug 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If patients were diagnosed with tumors
- Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
- The tumor location and size do not affect the dissection of hepatic hilar region
- Tumor size less than 10cm
- Without portal vein tumor thrombus
- Without intrahepatic or distant metastasis
Show all 12Show fewer
- Partial resection or half liver resection
- Willingness to participate in the study
- Able to understand the nature of the study and what will be required of them
- Body mass index of between 18 and 35
- Child-Pugh classification of A to B
- American Society of Anesthesiologists (ASA) grading of I to III
Who cannot join
- Pregnant or lactating women
- Unwillingness to participate
- Inability to give written informed consent
- Child-Pugh classification of C
- ASA grading of IV to V
- Tumor invasion of the inferior vena cava or confluence part of hepatic vein
- Decompensated liver cirrhosis
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
About this study
Official title: A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
Read the detailed description
The ERAS programs has been proved to be a useful solutions 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.
But few studies reported about the ERAS programs in the laparoscopic hepatectomy.
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
- Conditions
- Liver Diseases
- Being tested
- ERAS perioperative cares, Conventional perioperative cares
- Keywords
- enhanced recovery after surgery protocal, laparoscopic hepatectomy
- Medical subject headings
- Liver Diseases
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
- Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery
- Fluid restriction \& Management by pulse contour analysis or transesophageal doppler
- Early mobilization
- Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)
- Intravenous patient controlled analgesics (no opioids analgesics)
- Postoperative Nausea Active Control
- No nasogastric tube
- No drain insertion
- 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
- Drainage tube insertion if needed
| Study group | Role | What they receive |
|---|---|---|
| enhanced recovery after surgery protocal | Active comparator | ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols. Receives: Procedure: ERAS perioperative cares |
| Conventional perioperative cares | Active comparator | Conventional perioperative cares 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.
post-operative hospital stay
participants will be followed for the duration of hospital stay, an expected average of 6 days
Measured: up to 4 weeks after surgery
Recovering Rate
- No major complication
- Tolerance of semiliquid diet
- Normal activity
- Good pain control with analgesic-free or oral analgesics.
Measured: 6 days after surgery
Secondary outcomes (8)
Time to functional recovery (days from operation to functional recovery)
Normal or decreasing serum bilirubin Good pain control with oral analgesia only Tolerance of solid food No intravenous fluids Mobile independently or at the preoperative level All of the above is functional recovery.
Measured: up to 4 weeks after surgery
cost of hospitalization
medical expense
Measured: up to 1 month after surgery
Quality of life
EQ-5d health questionnaire and Kolcaba's GCQ (General Comfort Questionnaire), before the operation, on postoperation 1 day, postoperation 3 day, postoperation 5 day, postoperation 1 month
Measured: up to 1 month after surgery
operation time
Measured: the day of surgery
associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)
associated cytokines in peripheral blood were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4
Measured: before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day
liver function
liver function were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4, postoperation 1 month if PT ≥ 50% and TB ≥ 50 μmol/L， it supports the liver dysfunction.
Measured: up to 1 month after surgery
Visual Analog Score for pain
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days
Measured: up to 5 days after surgery
Estimated blood loss
blood loss during the operation
Measured: the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujun Cai, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533193
- Sponsor's protocol ID
- sirrrsh20150802-1
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
- ClinicalTrials.gov ID
- NCT02533193
- Acronym / sponsor ID
- sirrrsh20150802-1
- Conditions
- Liver Diseases
- Keywords
- enhanced recovery after surgery protocal, laparoscopic hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Aug 2015 (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.
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
Detailed description
The ERAS programs has been proved to be a useful solutions 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.
But few studies reported about the ERAS programs in the laparoscopic hepatectomy.
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced recovery after surgery protocal | Active comparator | Procedure: ERAS perioperative caresERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols. |
| Conventional perioperative cares | Active comparator | Procedure: Conventional perioperative caresConventional perioperative cares patents will be managed by our hospital's critical pathways. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- If patients were diagnosed with tumors
- Partial resection or half liver resection
- Willingness to participate in the study
- Able to understand the nature of the study and what will be required of them
- Body mass index of between 18 and 35
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Unwillingness to participate
- Inability to give written informed consent
- Child-Pugh classification of C
- ASA grading of IV to V
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. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery 4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet) 7. Intravenous patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. No nasogastric tube 10. No drain insertion 11. Patients will be discharged at POD#4 if there's no problem | Procedure or surgery | enhanced recovery after surgery protocal |
| 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. Drainage tube insertion if needed | Procedure or surgery | Conventional perioperative cares |
Primary outcome
post-operative hospital stay
Time frame: up to 4 weeks after surgery
participants will be followed for the duration of hospital stay, an expected average of 6 days
Recovering Rate
Time frame: 6 days after surgery
1. No major complication 2. Tolerance of semiliquid diet 3. Normal activity 4. Good pain control with analgesic-free or oral analgesics.
8 secondary outcomes
Time to functional recovery (days from operation to functional recovery)
Time frame: up to 4 weeks after surgery
cost of hospitalization
Time frame: up to 1 month after surgery
Quality of life
Time frame: up to 1 month after surgery
operation time
Time frame: the day of surgery
associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)
Time frame: before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day
liver function
Time frame: up to 1 month after surgery
Visual Analog Score for pain
Time frame: up to 5 days after surgery
Estimated blood loss
Time frame: the day of 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 15 Sep 2016.
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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 perioperative cares and Conventional perioperative cares in people with Liver Diseases, run by Sir Run Run Shaw Hospital at 1 site in China.
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 12 inclusion and 7 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 15 Sep 2016. 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 China. 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?
post-operative hospital stay (time frame: up to 4 weeks after surgery). The study lists 2 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 15 Sep 2016.