ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer (NCT06489288) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer
China2,656 participantsStarted 2024-05-01
Plain-language summary
The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18-80 years;
✓. ASA I-III;
✓. ECOG ≤2;
✓. NRS2002: 0-2;
✓. Preoperative gastroscopy and pathological biopsy confirmed adenocarcinoma;
✓. The clinical stage of abdominal hypotonic enhanced CT or ultrasonic gastroscopy is cT2-3N0-3M0 or cT1N+M0 or cT4aN0M0 (according to the AJCC-8thTNM tumor staging);
✓. Proposed D2 total laparoscopic radical gastrectomy (without limitation on the anastomotic method);
✓. All patients did not receive adjuvant radiotherapy, chemotherapy, or other cytotoxic treatments before surgery;
Exclusion criteria
✕. tumors at the esophagogastric junction or gastric tumors that have invaded the pyloric canal;
✕. Those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders;
✕. Severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe drug-dependent arrhythmia, or a history of myocardial infarction within the last 6 months;
✕. Patients with urinary dysfunction who require long-term indwelling catheters after surgery;
What they're measuring
1
QLQ-STO22
Timeframe: Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
2
QLQ-C30 (V3.0)
Timeframe: Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
. Patients who need immunosuppressive therapy for organ transplantation;
✕. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases;
✕. Moderate or severe renal impairment \[creatinine clearance equal to or lower than 50ml/min (calculated according to the Cockroft and Gault equation), or serum creatinine \> upper limit of normal (ULN);
✕. Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction);