Postoperative InflammationNCT03356626
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
A study testing ULTRACISION Harmonic Scalpel, Ligasure Maryland and Thunderbeat in people with Postoperative Inflammation and Postoperative Fever, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat comparing postoperative CRP level in each group Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Inflammation, Postoperative Fever
- What is being tested?
- ULTRACISION Harmonic Scalpel, Ligasure Maryland and Thunderbeat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2018to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pathologically proven adenocarcinoma in stomach
- patients who are expected for R0 resection with distal gastrectomy
- pre-operative clinical stage should be stage I
- patients who is able to be followed up with in postoperative 30 days
- patients whose CRP is normal before surgery
Who cannot join
- patients who had an abdominal surgery
- patients who received chemotherapy, radiotherapy before surgery
- patients who received ESD before surgery
- Patients who had an ascites on pre-operative CT scan
- liver cirrhosis
- cardiovascular disease (Ejection Fraction<50%)
Show all 14Show fewer
- serum creatinine > 1.4 mg/dL or BUN>26mg/dL
- PT INR >1.2 or aPTT>45sec
- uncontrolled diabetes
- Crohn's disease, ulcerative colitis
- patients who receives anti-coagulants
- patients who need pre-operative steroid booster because of steroid treatment
- pregnancy
- patients who have allergic reaction to iodine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
Read the detailed description
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
- post operative 2nd day CRP level
- post operative 4th day CRP level
- post operative IL-6, 10 level in 2nd, 4th day
- Conditions
- Postoperative Inflammation, Postoperative Fever
- Being tested
- ULTRACISION Harmonic Scalpel, Ligasure Maryland, Thunderbeat
- Keywords
- fever, inflammation
- Medical subject headings
- Fever, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRACISION Harmonic ScalpelDevice
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
Ligasure MarylandDevice
to use Ligasure Maryland when performing gastrectomy
ThunderbeatDevice
to use Thunderbeat when performing gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| ULTRACISION Harmonic Scalpel | Experimental | Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy Receives: Device: ULTRACISION Harmonic Scalpel |
| Ligasure Maryland | Experimental | Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Receives: Device: Ligasure Maryland |
| Thunderbeat | Experimental | Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Receives: Device: Thunderbeat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 2nd Day CRP
To check the postoperative 2nd day CRP level in each group
Measured: 2nd day
Secondary outcomes (5)
Postoperative 4th Day CRP
To check the postoperative 4th day CRP level in each group
Measured: 4th day
Postoperative 2nd Day IL-6
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Measured: 2nd day
Postoperative 4th Day IL-6
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Measured: 4th day
Postoperative 2nd Day IL-10 Level
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Measured: 2nd day
Postoperative 4th Day IL-10 Level
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start12 Mar 2018
- Primary completion7 Jan 2021
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative InflammationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Spine LLC
- Responsible party
- Sponsor
- Investigators
- Seong-Ho Kong, MD,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356626
- Sponsor's protocol ID
- EBD-02
- Status last verified
- May 2022
- First submitted
- 24 Nov 2017
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT03356626
- Acronym / sponsor ID
- EBD-02
- Conditions
- Postoperative Inflammation, Postoperative Fever
- Keywords
- fever, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic Spine LLC
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
Detailed description
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
- post operative 2nd day CRP level
- post operative 4th day CRP level
- post operative IL-6, 10 level in 2nd, 4th day
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ULTRACISION Harmonic Scalpel | Experimental | Device: ULTRACISION Harmonic ScalpelPatients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy |
| Ligasure Maryland | Experimental | Device: Ligasure MarylandPatients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy |
| Thunderbeat | Experimental | Device: ThunderbeatPatients group randomized to use Thunderbeat when receives laparoscopic gastrectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pathologically proven adenocarcinoma in stomach
- patients who are expected for R0 resection with distal gastrectomy
- pre-operative clinical stage should be stage I
- patients who is able to be followed up with in postoperative 30 days
- patients whose CRP is normal before surgery
Key exclusion criteria (14 listed)
- patients who had an abdominal surgery
- patients who received chemotherapy, radiotherapy before surgery
- patients who received ESD before surgery
- Patients who had an ascites on pre-operative CT scan
- liver cirrhosis
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 |
|---|---|---|
| ULTRACISION Harmonic Scalpelto use ULTRACISION Harmonic Scalpel when performing gastrectomy | Device | ULTRACISION Harmonic Scalpel |
| Ligasure Marylandto use Ligasure Maryland when performing gastrectomy | Device | Ligasure Maryland |
| Thunderbeatto use Thunderbeat when performing gastrectomy | Device | Thunderbeat |
Primary outcome
Postoperative 2nd Day CRP
Time frame: 2nd day
To check the postoperative 2nd day CRP level in each group
5 secondary outcomes
Postoperative 4th Day CRP
Time frame: 4th day
Postoperative 2nd Day IL-6
Time frame: 2nd day
Postoperative 4th Day IL-6
Time frame: 4th day
Postoperative 2nd Day IL-10 Level
Time frame: 2nd day
Postoperative 4th Day IL-10 Level
Time frame: 4th day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postoperative Inflammation
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain
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.
Seong-Ho Kong, MD,PhD principal investigator
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 ULTRACISION Harmonic Scalpel, Ligasure Maryland and Thunderbeat in people with Postoperative Inflammation and Postoperative Fever, 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 5 inclusion and 14 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 23 Sep 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 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative 2nd Day CRP (time frame: 2nd day). 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 23 Sep 2024.