An observational study in Gastrointestinal Stromal Tumors, sponsored by Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Fujian Medical University · Observational
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.
345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.
This study's planned enrollment of 194 is above the median of 128 across 69 observational studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who are assigned to undergo gastrectomy for gastric gastrointestinal stromal tumors are included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
laparoscopic resection of less than 5cm gastric gastrointestinal stromal tumors
Overall postoperative morbidity
This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
Time frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 1 day
Conversion to open surgery rate
Conversion to open surgery rate is defined as the rate of open surgery whatever the reason
Time frame: 1 day
Positive surgical margin rate
Positive surgical margin rate
Time frame: 1 day
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Time frame: Preoperative 7 days and postoperative 1, 3, and 5 days
overall postoperative serious morbidity rates
According to the Clavien-Dindo complication scoring system, grade IIIA and above is a serious complication, and when multiple complications occur at the same time, the complication with the highest grade will prevail.
Time frame: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
Time to first ambulation
Time to first ambulation in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 30 days
3-year overall survival rate
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months
3-year recurrence pattern
Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type
Time frame: 36 months
Plan to share: No
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