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出境医 / 临床实验 / Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer (LCFRAGIGC)
Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer (LCFRAGIGC)
Study Description
Brief Summary:
The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve.
| Condition or disease |
|---|
| Stomach Neoplasms |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer |
| Actual Study Start Date : | October 1, 2017 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | February 28, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Operation time,min [ Time Frame: 1 week ]The surgeon begins the operation until the incision is closed
- Docking time,min [ Time Frame: 1 week ]From the skin cutting through the observation hole to the robot moving to the designated position, the lens and the instrument arm enter the abdominal cavity and prepare for this period
Secondary Outcome Measures :
- Evaluated blood loss ,ml [ Time Frame: 1 week ]The amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze
- Number of retrieved lymph nodes [ Time Frame: 1 week ]Refer to the postoperative pathology report
- Day of first flatus,day [ Time Frame: 2 week ]
- Day of first fluid diet,day [ Time Frame: 2 week ]
- the rate of postoperative complications [ Time Frame: 30 days after the operation ]Postoperative complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage
- postoperative hospital stay, days [ Time Frame: 30 days after the operation ]Length of postoperative hospital stay
- cost [ Time Frame: 30 days after the operation ]total cost in the hospital
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients were scheduled to undergo minimally invasive gastric cancer surgery and meet the above conditions
Criteria
Inclusion Criteria:
- 1.Patients were 18-90 years old
- 2. Patients with a documented diagnosis of gastric adenocarcinoma
- 3. patients were scheduled to undergo minimally invasive gastric cancer surgery
- 4.patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound
Exclusion Criteria:
- 1. Patients with neoadjuvant treatment
- 2. Patients procedure concurrent with the gastrectomy
- 3.Patients with palliative surgery
- 4. Patients with the contraindications for general anesthesia
- 5. Patients were pregnant or mentally incompetent
- 6. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension
Contacts and Locations
Contacts
| Contact: Junjun She, MD,PHD | 0086-18991232713 | junjunshe1975@sina.com |
Locations
| China, Shaanxi | |
| the First Affiliated Hospital of Xi'an Jiao Tong University | Recruiting |
| Xi'an, Shaanxi, China, 710061 | |
| Contact: Bingyin Shi, MD,PHD | |
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | November 18, 2018 | ||||
| First Posted Date | May 7, 2019 | ||||
| Last Update Posted Date | May 7, 2019 | ||||
| Actual Study Start Date | October 1, 2017 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer | ||||
| Official Title | Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer | ||||
| Brief Summary | The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients were scheduled to undergo minimally invasive gastric cancer surgery and meet the above conditions | ||||
| Condition | Stomach Neoplasms | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | February 28, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03940417 | ||||
| Other Study ID Numbers | XJTU1AF2019LSK-005 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Study Sponsor | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Verification Date | November 2018 | ||||
