Fast-track Surgery After Gynecological Oncology Surgery

Ling Cui

Status: Completed

Conditions: Postoperative Complications; CRP; Length of Stay

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02687412

SichuanCHRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Fast-track Surgery

Experimental group

Description:

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).

Treatment:

Procedure: fast solid

Procedure: preoperative treatment with carbohydrates

Procedure: avoiding hypothermia

Procedure: bowel preparation

Procedure: postoperative nausea and vomiting (PONV) control;

Procedure: pre-operative assessment, counseling and education

Procedure: Preoperative nutritional drink up to 4 h prior to surgery

Procedure: early postoperative diet

Procedure: Postoperative glycaemic control

Traditional surgery

Other group

Description:

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

Treatment:

Procedure: bowel preparation for traditional surgery

Procedure: began to take solid diet after anal exhaust

Procedure: pre-operative fasting at least 8h