An interventional study of 3D Laparoscopic Surgery and 2D Laparoscopic Surgery in Stomach Neoplasms, sponsored by Fujian Medical University. Completed. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Fujian Medical University · Not applicable, Interventional, and Prevention
The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.
A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's enrollment of 438 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Procedure: 3D Laparoscopic Surgery
2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Procedure: 2D Laparoscopic Surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
Operating time
Operating time
Time frame: 1 day
Intraoperative situation
The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy
Time frame: 1 day
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Time frame: 10 days
Complication
Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome
Time frame: 30 days;36 months
The postoperative pathology
The postoperative pathological type and pTNM stage.
Time frame: 7 days
Inflammatory and immune response
The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Time frame: 30 days;36 months
Hospitalization expenses
The cost from admission to discharge
Time frame: 1 months
3-year disease free survival rate
Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time frame: 36 months
3-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 36 months
5-year disease free survival rate
Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time frame: 60 months
5-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 60 months
Recurrence patterns
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 60 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Fujian Medical University