Fast-track Surgery After Gynecological Oncology Surgery

Not Applicable

Completed

• Conditions: Length of Stay; Postoperative Complications; CRP
• Interventions: Procedure: pre-operative fasting at least 8h; Procedure: pre-operative assessment, counseling and education; Procedure: Preoperative nutritional drink up to 4 h prior to surgery; Procedure: bowel preparation for traditional surgery; Procedure: bowel preparation; Procedure: began to take solid diet after anal exhaust; 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

• Registration Number: NCT02687412
• Lead Sponsor: Ling Cui

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.

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Study Start: 2016-11-21
• Primary Completion: 2017-09-02
• Study Completion: 2018-03-21
• Results First Submitted: 2018-04-23
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-25
• Last Update Submitted: 2019-08-25
• Results First Posted: 2019-09-26
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

1. Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
2. Aged 18 years or older
3. Signed informed consent provided

Exclusion Criteria

1. Patients with a documented infection at the time of operation
2. Aged 71 years or older
3. Patients with ileus at the time of operation
4. Patients with hypocoagulability
5. Patients with psychosis, Alcohol dependence or drug abuse history
6. Patients with primary nephrotic or hepatic disease
7. Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure>90mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Length of Hospitalization Post-operation	up to 12 months	days from operation date to discharge date
The Total Cost (RMB)	12 month	The total cost from hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LinShuangfeng; 🇨🇳 Leshan, Sichuan, China