NCT02687412

Fast-track Surgery After Gynecological Oncology Surgery

Fast-track Surgery After Gynaecological Oncological Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Ling Cui · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Length of Stay
• Postoperative Complications
• CRP

Interventions

Type	Name	Description
PROCEDURE	pre-operative assessment, counseling and education	pre-operative assessment, counseling and FT management education
PROCEDURE	Preoperative nutritional drink up to 4 h prior to surgery	Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used
PROCEDURE	bowel preparation	patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool
PROCEDURE	preoperative treatment with carbohydrates	preoperative treatment with carbohydrates (patients without diabetes).
PROCEDURE	fast solid	fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;
PROCEDURE	avoiding hypothermia	avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
PROCEDURE	Postoperative glycaemic control	Postoperative glycaemic control;
PROCEDURE	postoperative nausea and vomiting (PONV) control;
PROCEDURE	early postoperative diet	early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
PROCEDURE	pre-operative fasting at least 8h
PROCEDURE	bowel preparation for traditional surgery	Oral bowel preparations or mechanical bowl until liquid stool
PROCEDURE	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

Timeline

• Start date: 2016-11-21
• Primary completion: 2017-09-02
• Completion: 2018-03-21
• First posted: 2016-02-22
• Last updated: 2019-09-26
• Results posted: 2019-09-26

Locations

1 site across 1 country: China