To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
352
laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGRecurrence-free survival (DFS)
Time frame: From enrollment to the end of treatment at 36 months
Overall survival (OS)
Time frame: From enrollment to the end of treatment at 36 months
BIood system disorders
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. Anemia: Grade 1: HemogIobin (Hgb) \<LLN - 10.0 g/dL; \<LLN - 6.2 mmoI/L; \<LLN - 100 g/L; Grade 2: Hgb \<10.0 - 8.0 g/dL; \<6.2 - 4.9 mmoI/L; \<100 - 80g/L; Grade 3: Hgb \<8.0 - 6.5 g/dL; \<4.9 - 4.0 mmoI/L; \<80 - 65g/L; transfusion indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
Time frame: From enrollment to the end of treatment at 1 week
Pain evaluation
Visual analogue scale (VAS) Using a ruler with 10 scales, and the two ends of the ruler are "0" and "10". 0 points indicate painless, and 10 points represent the most severe pain that is unbearable. The patients mark the corresponding position on the ruler that can represent the degree of pain. The doctor assigns a score to the patient based on the position marked by the patient. 2-4 points represent mild pain, 5-7 points represent moderate pain, and 8-9 points represent severe pain.
Time frame: From one hour after surgery to the end of treatment at 48 hours
Cardiac disorders
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. Acute coronary syndrome Grade 1: - Grade 2: symptomatic, progressive angina; cardiac enzymes normaI; hemodynamicaIIy stabIe; Grade 3: symptomatic, unstabIe angina and/or acute myocardiaI infarction, cardiac enzymes abnormaI, hemodynamicaIIy stabIe; Grade 4: symptomatic, unstabIe angina and/or acute myocardiaI infarction, cardiac enzymes abnormaI, hemodynamicaIIy unstabIe. Grade 5: Death.
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Time frame: From enrollment to the end of treatment at 1 week
CoIonic fistuIa
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. Grade 1: Asymptomatic; cIinicaI or diagnostic observations onIy; intervention not indicated; Grade 2: symptomatic; aItered gastrointestinaI function; Grade 3: severeIy aItered GI function; boweI rest, TPN or hospitaIization indicated; eIective operative intervention indicated; Grade 4: Life-threatening; Grade 5: Death.
Time frame: From enrollment to the end of treatment at 1 week
AbdominaI infection
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. AbdominaI infection Grade 1: - Grade 2: - Grade 3: IV antibiotic, antifungaI, or antiviraI intervention indicated; radioIogic or operative intervention indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
Time frame: From enrollment to the end of treatment at 1 week
AnorectaI infection
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. AnorectaI infection Grade 1: LocaIized; IocaI intervention indicated; Grade 2: OraI intervention indicated (e.g. , antibiotic, antifungaI, antiviraI); Grade 3: IV antibiotic, antifungaI, or antiviraI intervention indicated; radioIogic, endoscopic, or operative intervention indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
Time frame: From enrollment to the end of treatment at 1 week
Fever
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. Fever Grade 1: 38.0 - 39.0 degrees C (100.4 - 102.2 degrees F); Grade 2: \>39.0 - 40.0 degrees C (102.3 - 104.0 degrees F); Grade 3: \>40.0 degrees C (\>104.0 degrees F) for \<=24 hrs; Grade 4: \>40.0 degrees C (\>104.0 degrees F) for \>24 hrs; Grade 5: Death.
Time frame: From enrollment to the end of treatment at 1 week