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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
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
preoperative treatment with carbohydrates (patients without diabetes).
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.
Postoperative glycaemic control;
early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
Oral bowel preparations or mechanical bowl until liquid stool
6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
LinShuangfeng
Leshan, Sichuan, China
Length of Hospitalization Post-operation
days from operation date to discharge date
Time frame: up to 12 months
The Total Cost (RMB)
The total cost from hospitalization
Time frame: 12 month
CRP
C-Reactive protein mg/L
Time frame: 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.
Time frame: up to 12 months
Number of Participants With Infection,
infection(wound infection, lung infection, intraperitoneal infection, operation space infection)
Time frame: 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
Time frame: up to 12 months
Number of Participants With Ileus
is a disruption of the normal propulsive ability of the gastrointestinal tract
Time frame: up to 12 months
Number of Participants With Postoperative Haemorrhage
Evidence of blood loss from drains or based on ultrasonography
Time frame: up to 12 months
Number of Participants With Postoperative Thrombosis
Evidence of blood thrombosis of participants after surgery
Time frame: up to 12 months
PCT Calcitonin Postoperative
value of calcitonin postoperative
Time frame: 12 month
Cost of Surgical Therapy
Cost of surgical therapy (RMB)
Time frame: 12 month
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