Trial Outcomes & Findings for Fast-track Surgery After Gynecological Oncology Surgery (NCT NCT02687412)

NCT ID: NCT02687412

Last Updated: 2019-09-26

Results Overview

days from operation date to discharge date

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 107 participants
• Primary outcome timeframe: up to 12 months
• Results posted on: 2019-09-26

Participant Flow

Participant milestones

Measure	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).	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
Overall Study STARTED	50	57
Overall Study COMPLETED	50	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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	Total n=107 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=57 Participants	0 Participants n=107 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=50 Participants	53 Participants n=57 Participants	100 Participants n=107 Participants
Age, Categorical >=65 years	3 Participants n=50 Participants	4 Participants n=57 Participants	7 Participants n=107 Participants
Age, Continuous	49 years STANDARD_DEVIATION 9.70 • n=50 Participants	50 years STANDARD_DEVIATION 10.52 • n=57 Participants	49 years STANDARD_DEVIATION 10.10 • n=107 Participants
Sex: Female, Male Female	50 Participants n=50 Participants	57 Participants n=57 Participants	107 Participants n=107 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=57 Participants	0 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	50 participants n=50 Participants	57 participants n=57 Participants	107 participants n=107 Participants
Body surface area	1.5462 m^2 STANDARD_DEVIATION 0.11873 • n=50 Participants	1.5362 m^2 STANDARD_DEVIATION 0.11550 • n=57 Participants	1.5409 m^2 STANDARD_DEVIATION 0.11658 • n=107 Participants
Body Mass Index	22.681 kg/m^2 STANDARD_DEVIATION 4.1774 • n=50 Participants	23.165 kg/m^2 STANDARD_DEVIATION 3.2728 • n=57 Participants	22.939 kg/m^2 STANDARD_DEVIATION 3.7722 • n=107 Participants

PRIMARY outcome

Timeframe: up to 12 months

days from operation date to discharge date

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Length of Hospitalization Post-operation	8.92 days Standard Deviation 2.029	9.67 days Standard Deviation 3.119

PRIMARY outcome

Timeframe: 12 month

The total cost from hospitalization

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
The Total Cost (RMB)	38882.44 RMB Standard Deviation 8557.800	42864.12 RMB Standard Deviation 10166.535

SECONDARY outcome

Timeframe: up to 12 months

C-Reactive protein mg/L

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
CRP	42.125 mg/L Standard Deviation 28.4284	62.499 mg/L Standard Deviation 37.7870

SECONDARY outcome

Timeframe: up to 12 months

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.

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Complications	3 Participants	13 Participants

SECONDARY outcome

Timeframe: up to 12 months

infection(wound infection, lung infection, intraperitoneal infection, operation space infection)

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Infection,	2 Participants	12 Participants

SECONDARY outcome

Timeframe: up to 12 months

it was recognized that nausea and vomiting are common side effects of surgical recovery

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Postoperative Nausea and Vomiting (PONV)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 12 months

is a disruption of the normal propulsive ability of the gastrointestinal tract

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Ileus	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 12 months

Evidence of blood loss from drains or based on ultrasonography

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Postoperative Haemorrhage	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 12 months

Evidence of blood thrombosis of participants after surgery

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Number of Participants With Postoperative Thrombosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 month

value of calcitonin postoperative

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
PCT Calcitonin Postoperative	0.6275 μg/L Standard Deviation 0.90827	0.7280 μg/L Standard Deviation 0.89083

SECONDARY outcome

Timeframe: 12 month

Cost of surgical therapy (RMB)

Outcome measures

Measure	Fast-track Surgery n=50 Participants 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).	Traditional Surgery n=57 Participants 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
Cost of Surgical Therapy	9703.22 RMB Standard Deviation 1739.157	9538.47 RMB Standard Deviation 1548.385

Adverse Events

Fast-track Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Cui Ling

SichuanCHRI

Phone: +8618181422637

Email: cuiling1985@qq.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place