Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Location status: Recruiting
NCT Number: NCT03716089
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Fuzhou, Fujian, 350001, China
Location status: Recruiting
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic surgery under general anesthesia
Time frame: 36 months
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
(4)Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.
Time frame: 36 months
Time frame: 36 months
Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
Time frame: 30 days
Time frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 1 day
Intraoperative tumor rupture rates are used to access the oncological safety of the intervention.
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The variation of album in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The variation of hemoglobin in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life.
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The values of white blood cell count from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
Time frame: Preoperative 7 days and postoperative 1 and 5 days
The values of C-reactive protein IN milligram/liter from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response.
Fujian Medical University
Other
Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site(FUGES-016)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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