Stomach NeoplasmsCooladvrsigcrNCT03447106
Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection.
A study testing laparotomy, Laparoscopic and Robotic in people with Stomach Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- laparotomy, Laparoscopic and Robotic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2018to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients without contraindications gastroscope，surgery and anesthesia;
- There is no history of abdominal surgery, no severe abdominal cavity adhesion
- Patients signed informed consent
Who cannot join
- Patients with preoperative assessment of distant metastasis;
- Patients with preoperative radiation and chemotherapy or hormone therapy;
- Patients with acute obstruction, bleeding or perforation of the emergency surgery
- Patients with a history of abdominal trauma or abdominal surgery.
- Patients with contraindications gastroscope，surgery and anesthesia;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jun Jun She, M.D.;Ph.D., 0086-18991232713, sjuns@sina.com
About this study
Official title: An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.
- Conditions
- Stomach Neoplasms
- Being tested
- laparotomy, Laparoscopic, Robotic
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparotomyProcedure or surgery
This is a kind of traditional surgical method.
LaparoscopicProcedure or surgery
laparoscopic surgery
RoboticProcedure or surgery
the Da Vinci robot assisted gastric resection
| Study group | Role | What they receive |
|---|---|---|
| Open | Experimental | Not described Receives: Procedure: laparotomy |
| Laparoscopic | Experimental | Not described Receives: Procedure: Laparoscopic |
| Robotic | Experimental | Not described Receives: Procedure: Robotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence rate
Measured: 2 years
cost of treatment
Measured: 2 years
Secondary outcomes (1)
the operation time
Measured: one hour-six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start28 Feb 2018 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Jun Jun She, M.D; PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447106
- Sponsor's protocol ID
- XJTU1AF-CRF-2018-001
- Acronym
- Cooladvrsigcr
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
- ClinicalTrials.gov ID
- NCT03447106
- Acronym / sponsor ID
- Cooladvrsigcr / XJTU1AF-CRF-2018-001
- Conditions
- Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 28 Feb 2018 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Feb 2018 (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.
Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open | Experimental | Procedure: laparotomy |
| Laparoscopic | Experimental | Procedure: Laparoscopic |
| Robotic | Experimental | Procedure: Robotic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients without contraindications gastroscope，surgery and anesthesia;
- There is no history of abdominal surgery, no severe abdominal cavity adhesion
- Patients signed informed consent
Key exclusion criteria (5 listed)
- Patients with preoperative assessment of distant metastasis;
- Patients with preoperative radiation and chemotherapy or hormone therapy;
- Patients with acute obstruction, bleeding or perforation of the emergency surgery
- Patients with a history of abdominal trauma or abdominal surgery.
- Patients with contraindications gastroscope，surgery and anesthesia;
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 |
|---|---|---|
| laparotomyThis is a kind of traditional surgical method. | Procedure or surgery | Open |
| Laparoscopiclaparoscopic surgery | Procedure or surgery | Laparoscopic |
| Roboticthe Da Vinci robot assisted gastric resection | Procedure or surgery | Robotic |
Primary outcome
Tumor recurrence rate
Time frame: 2 years
cost of treatment
Time frame: 2 years
1 secondary outcome
the operation time
Time frame: one hour-six hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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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.
Jun Jun She, M.D; PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparotomy, Laparoscopic and Robotic in people with Stomach Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University 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 3 inclusion and 5 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 2 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Jun She, M.D; PhD (008618991232713, sjuns@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence rate (time frame: 2 years). 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 2 Mar 2018.