| Primary | Length of Hospitalization Post-operation | days from operation date to discharge date | | Posted | | Mean | Standard Deviation | days | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0008.92± 2.029
- OG0019.67± 3.119
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.141 | | | | | | | | | | | | | | Superiority | | |
|
| Primary | The Total Cost (RMB) | The total cost from hospitalization | | Posted | | Mean | Standard Deviation | RMB | | 12 month | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | CRP | | | Posted | | Mean | Standard Deviation | mg/L | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Complications | Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis. | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Infection, | infection(wound infection, lung infection, intraperitoneal infection, operation space infection) | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Postoperative Nausea and Vomiting (PONV) | it was recognized that nausea and vomiting are common side effects of surgical recovery | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Ileus | is a disruption of the normal propulsive ability of the gastrointestinal tract | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Postoperative Haemorrhage | Evidence of blood loss from drains or based on ultrasonography | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Number of Participants With Postoperative Thrombosis | Evidence of blood thrombosis of participants after surgery | | Posted | | Count of Participants | | Participants | | up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | PCT Calcitonin Postoperative | value of calcitonin postoperative | | Posted | | Mean | Standard Deviation | μg/L | | 12 month | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|
| Secondary | Cost of Surgical Therapy | Cost of surgical therapy (RMB) | | Posted | | Mean | Standard Deviation | RMB | | 12 month | | | | ID | Title | Description |
|---|
| OG000 | Fast-track Surgery | Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | | OG001 | Traditional Surgery | pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust pre-operative fasting at least 8h Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
|