Fast-track Surgery After Gynecological Oncology Surgery

Study Overview
=================
Brief Summary
-----------------
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now. The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction. The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Detailed Description
-----------------
Methods/Design Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are 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 and APACHE II score. The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Official Title
-----------------
Fast-track Surgery After Gynaecological Oncological Surgery

Conditions
-----------------
Length of Stay, Postoperative Complications, CRP

Intervention / Treatment
-----------------
* Procedure: pre-operative assessment, counseling and education
* Procedure: Preoperative nutritional drink up to 4 h prior to surgery
* Procedure: bowel preparation
* Procedure: preoperative treatment with carbohydrates
* Procedure: fast solid
* Procedure: avoiding hypothermia
* Procedure: Postoperative glycaemic control
* Procedure: postoperative nausea and vomiting (PONV) control;
* Procedure: early postoperative diet
* Procedure: pre-operative fasting at least 8h
* Procedure: bowel preparation for traditional surgery
* Procedure: began to take solid diet after anal exhaust


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive) Aged 18 years or older Signed informed consent provided Exclusion Criteria: Patients with a documented infection at the time of operation Aged 71 years or older Patients with ileus at the time of operation Patients with hypocoagulability Patients with psychosis, Alcohol dependence or drug abuse history Patients with primary nephrotic or hepatic disease Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure>90mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-track Surgery<br>Pre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，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 temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery). | Procedure: pre-operative assessment, counseling and education<br>* pre-operative assessment, counseling and FT management education<br>Procedure: Preoperative nutritional drink up to 4 h prior to surgery<br>* Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used<br>Procedure: bowel preparation<br>* patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool<br>Procedure: preoperative treatment with carbohydrates<br>* preoperative treatment with carbohydrates (patients without diabetes).<br>Procedure: fast solid<br>* fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;<br>Procedure: avoiding hypothermia<br>* avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.<br>Procedure: Postoperative glycaemic control<br>* Postoperative glycaemic control;<br>Procedure: postoperative nausea and vomiting (PONV) control;<br> <br> Procedure: early postoperative diet<br>* early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).<br>|
| Other: Traditional surgery<br>pre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, 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 | Procedure: pre-operative fasting at least 8h<br> <br> Procedure: bowel preparation for traditional surgery<br>* Oral bowel preparations or mechanical bowl until liquid stool<br>Procedure: began to take solid diet after anal exhaust<br>* 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospitalization Post-operation | days from operation date to discharge date | up to 12 months | 
| The Total Cost (RMB) | The total cost from hospitalization | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | C-Reactive protein mg/L | up to 12 months | 
| 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. | up to 12 months | 
| Number of Participants With Infection, | infection(wound infection, lung infection, intraperitoneal infection, operation space infection) | up to 12 months | 
| Number of Participants With Postoperative Nausea and Vomiting (PONV) | it was recognized that nausea and vomiting are common side effects of surgical recovery | up to 12 months | 
| Number of Participants With Ileus | is a disruption of the normal propulsive ability of the gastrointestinal tract | up to 12 months | 
| Number of Participants With Postoperative Haemorrhage | Evidence of blood loss from drains or based on ultrasonography | up to 12 months | 
| Number of Participants With Postoperative Thrombosis | Evidence of blood thrombosis of participants after surgery | up to 12 months | 
| PCT Calcitonin Postoperative | value of calcitonin postoperative | 12 month | 
| Cost of Surgical Therapy | Cost of surgical therapy (RMB) | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fast-track surgery, Gynecological oncology, Hospitalization post-operation, Complication