Time | Fast track treatment | Conventional treatment |
---|---|---|
Preadmission | -Psychological optimism | -No psychological optimism |
(After randomization) | -Pre-assessment for risk adjustment | -Pre-assessment for risk adjustment |
-Anesthesiologic information of combined anesthesia consisting of thoracic epidural and general anesthesia | -No Anesthesiologic information of general anesthesia | |
-Information of the fast track treatment and the informed consent | -Information of the conventional treatment and the informed consent | |
-Guided tour of fast track wards | -No tour | |
-Operation schedule | -Operation schedule | |
Preoperation | -Bowel preparation: semiliquid diet 1 days before operation | -Bowel preparation: liquid diet 1-2 days before operation |
- Enemas: | -Enemas: | |
Polyethylene Glycol-Electrolyte Powder ® (Hengkang Zhengqing™, Jiangxi Hygecon Pharmacy CO., Ltd, Shangrao, CN) the afternoon before surgery,2 boxes mixing with 2,000 ml warm drinking water | Polyethylene Glycol-Electrolyte Powder ® the afternoon before surgery, 2 boxes mixing with 2000 ml warm drinking water | |
-Fasting: last meal 2 h before operation | -Fasting: last meal 10 h before operation | |
-Complete Enteral Nutritional Emulsion Supportan (TPF-T) ® (Supportan™, Sino-Swed Pharmaceutical CO. Ltd, Wuxi, CN) 600 ml or Fresubin Diabetes (TPF-D) ® (Fresubin Diabetes™, Sino-Swed Pharmaceutical CO. Ltd, Wuxi, CN) 500 ml (especially for patients with diabetes mellitus) p.o. 8 h before operation | - No oral intake in the operation day | |
- 10% Glucose 400 ml p.o. 2-3 h before operation | - No oral intake in the operation day | |
- Nasogastric tube 0.5 h before operation for Gastrointestinal decompression | - Nasogastric tube 0.5 h before operation for Gastrointestinal decompression | |
Intraoperation | ||
-Anesthetic managemen | - Placement of epidural catheter (T6-L1), depending on the surgical resection); test-dose (3 ml of 2% lidocaine (Hefengâ„¢, Harvest Pharmaceutical CO. Ltd, Shanghai, CN)) followed by continuous infusion (10 ml of 0.5% or 0.75% ropivacaine(Naropinâ„¢, APP Pharmaceuticals, LLC., Schaumburg, IL) according to the age and size of the patient before surgical incision | - No thoracic epidural anesthesia |
- Balanced Combination with general anesthesia: intravenous midazolam (Liyuexi™, Nhwa Pharmaceutical Co., Ltd., Xuzhou, CN) (0.1 mg/kg), target-controlled infusion (TCI) of propofol (Diprivan™, AstraZeneca Pharmaceutical Co., Ltd., Shanghai, CN) (4-8 μg/ml), sufentanil (Fukang™, Humanwell Pharmaceutical Co., Ltd., Yichang, CN) (0.5-1 µg/kg), rocuronium (Esmeron™, Organon Teknika B.V., Oss, NL) (0.6-0.9 mg/kg). | - Normal General anesthesia: intravenous midazolam (0.1 mg/kg), target-controlled infusion (TCI) of propofol (4-8 μg/ml), sufentanil 0.5-1 µg/kg, rocuronium (0.6-0.9 mg/kg). | |
The patients were ventilated mechanically. | The patients were ventilated mechanically. | |
Anesthesia was maintained propofol TCI (2-4 μg/ml), remifentanil (0.02-0.03 μg/kg/min) and intermittent boluses of rocuronium. | Anesthesia was maintained propofol TCI (2-4 μg/ml), remifentanil (Ruijie™, Humanwell Pharmaceutical Co., Ltd., Yichang, CN) (0.02-0.03 μg/kg/min) and intermittent boluses of rocuronium. | |
As equally depth of anesthesia is also needed in conventional treatment group with no thoracic epidural anesthesia, more drug dosage of general anesthesia is used. | ||
- Morphia as little as possible | - No restriction of Morphia use | |
- Monitoring: (Datex Ohmedaâ„¢ S/5 Anesthesia Monitor (Datex-Ohmeda Division, Instrumentarium Corp., Helsinki, Finland)) consists of electrocardiogram (ECG), heart rate (HR), respiratory rate, arterial pressure (BP), SpO2, end-tidal CO2 (etCO2), and bispectral index (BIS). - The target concentration of propofol:keep BIS between 40 and 60 to maintain adequate hypnosis. - Perioperative hypotension:systolic blood pressure (SBP) < 80 mmHg or a decrease of 30% baseline value and was treated with reduction of anesthetics, fluid supplement, and a bolus dose of ephedrine (Mahuangsuâ„¢, Northeast Pharmaceutical Co., Ltd., Shenyang, CN) (10 mg, IV). If SBP was above 160 mmHg or increase > 30%, an increase of propofol or remifentanil infusion was given to deepen anesthesia. | - Monitoring: the same as fast-track group | |
-Antibiotic prophylaxis | - Yes, | - Yes |
-Surgical management | -Laparoscopic/open surgery as randomization | -Laparoscopic/open surgery as randomization |
- Warming | - Yes, body warming by thickening quilt as well as intravenous fluid warming | - No body and intravenous fluid warming |
- Drains | - Minimal use and early removal of abdominal drains | -Regularly use and removal of abdominal drains |
- Fluid infusion | - Totally ≤ 1,500 ml during operation | - No restriction |
Postoperation | ||
- Pain management | -Patient-controlled continuous epidural analgesia with a 5 ml/h continuous infusion of 0.15% ropivacaine and a bolus dose of 2.5 ml (locktime 15 min) until 48 h after operation, paracetamol (Tylenol™, Johnson & Johnson Pharmaceutical Co., Ltd., Shanghai, CN) p.o. when needed | -Patient-controlled intravenous analgesia with a 4 ug/h continuous infusion of sufentanil and a bolus dose of 1.5 μg (locktime 15 min) |
-Bucinperazine (QiangtongdingTM, Northeast Pharmaceutical Co., Ltd., Shenyang, CN) or Morphine (Mafeiâ„¢, Northeast Pharmaceutical Co., Ltd., Shenyang, CN) intramuscular injection when patient-controlled intravenous analgesia isn't enough for pain control | ||
- Diet | - Chewing gum 1 piece tid p.o. | -No chewing gum |
- At least 10% Glucose 200 ml p.o. within 24 h after operation | - Fasting until flatus | |
-Liquid diet and Enteral Nutritional Emulsion Supportan 200 ml or Fresubin Diabetes 300 ml (especially for patients with diabetes mellitus) p.o. the next day of operation | - Liquid diet after flatus | |
- Diet rehabilitation as early as possible (dose increase of Enteral Nutritional Emulsion or when needed) | - Normal diet after defecation | |
- Intravenous fluid infusion | - Stop intravenous high energy fluid infusion after dosage of Enteral Nutritional Emulsion Supportan ≥ 600 ml or Enteral Nutritional Emulsion Fresubin Diabetes ≥ 500 ml | - Intravenous high energy fluid infusion on daily basis and continuing until adequate oral intake |
- No intravenous High-energy Nutrient Fluid after 72 h post-surgery | ||
- Restricting and avoiding excessive intravenous fluid infusion, keeping body weight as pre-surgery | ||
- Energy | - Keep the total energy intake (both diet and intravenous fluid infusion) 25-30 kcal/kg/day | - Keep the total energy intake (both diet and intravenous fluid infusion) 25-30 kcal/kg/day |
- Nasogastric tube and urethral catheter | -Remove nasogastric tube as soon as the end of operation | - Remove nasogastric tube after 1st flatus postoperation |
- Remove urethral catheter within 24-48 h after operation | -Remove urethral catheter when 1st time meet: patient have the feeling of automatic micturition and ≧200 ml after valving-on urethral catheter | |
- Ambulation | - Forced ambulation within 24 h post-surgery, no time restriction | - No ambulation scheme |
- Ambulation time ≥ 1 h per day, and increasing day by day | ||
- Patients walking to weight themselves every day | ||
Adjuvant | ||
chemotherapy | - Xelox | - mFolfox6 |
- repeat every 3 weeks for 8 cycles | - repeat every 2 weeks for 12 cycles | |
- Regimen | - Regimen | |
Oxaliplatin 130 mg/m2 day 1, Capecitabine (Xeloda™) 850-1,000 mg/m2 twice daily for 14 days - | Oxaliplatin (EloxatinTM) 85 mg/m2 IV over 2 hours, day .1 Leucovorin (Tongao™) 400 mg/m2 IV over 2 hours, day 1. 5-FU (Jinyao™) 400 mg/m2 IV bolus on day 1, then 1,200 mg/m2/day × 2 days (total 2,400 mg/m2 over 46-48 hours) continuous infusion | |
- No peripherally inserted central catheter (PICC) | - Peripherally inserted central catheter and care of PICC in outpatient clinic every week | |
- Hospitalization no more than 24 h each cycle | - Hospitalization for 3 days each cycle |