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Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer (LCFRAGIGC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940417
Recruitment Status : Unknown
Verified November 2018 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940417


Contacts
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Contact: Junjun She, MD,PHD 0086-18991232713 junjunshe1975@sina.com

Locations
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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
More Information
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03940417    
Other Study ID Numbers: XJTU1AF2019LSK-005
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases