Fast-track Surgery After Gynecological Oncology Surgery

NCT02687412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-09-26

Study results available
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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.

Conditions

  • Length of Stay
  • Postoperative Complications
  • CRP

Interventions

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

Sponsors & Collaborators

  • Ling Cui

    lead OTHER

Principal Investigators

  • Ling Cui, MD · Sichuan Cancer Hospital and Research Institute

  • Yu Shi · Sichuan Cancer Hospital and Research Institute

  • Hong Liu · Sichuan Cancer Hospital and Research Institute

  • Dengfeng Wang · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2017-09-02
Completion
2018-03-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687412 on ClinicalTrials.gov