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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Clinicaltrials.gov identifier NCT03940417

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

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
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

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 2017
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: February 2020
Outcome Measures
  • Primary Outcome Measures: 1. Operation time,min [ Time Frame: 1 week ]
    The surgeon begins the operation until the incision is closed
  • 2. 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: 1. 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
  • 2. Number of retrieved lymph nodes [ Time Frame: 1 week ]
    Refer to the postoperative pathology report
  • 3. Day of first flatus,day [ Time Frame: 2 week ]
  • 4. Day of first fluid diet,day [ Time Frame: 2 week ]
  • 5. 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
  • 6. postoperative hospital stay, days [ Time Frame: 30 days after the operation ]
    Length of postoperative hospital stay
  • 7. cost [ Time Frame: 30 days after the operation ]
    total cost in the hospital
Eligibility Criteria
  • Ages Eligible for Study: 18 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
Xi'an

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

More Information
  • Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
  • ClinicalTrials.gov Identifier: NCT03940417 History of Changes
  • Other Study ID Numbers: XJTU1AF2019LSK-005
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: November 2018
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Stomach Neoplasms