Fast-track Surgery After Gynecological Oncology Surgery

August 25, 2019 updated by: Ling Cui

Fast-track Surgery After Gynaecological Oncological Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Leshan, Sichuan, China, 610000
        • LinShuangfeng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast-track 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).
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).
Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospitalization Post-operation
Time Frame: up to 12 months
days from operation date to discharge date
up to 12 months
The Total Cost (RMB)
Time Frame: 12 month
The total cost from hospitalization
12 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ling Cui

Investigators

  • Study Chair: Ling Cui, MD, Sichuan Cancer Hospital and Research Institute
  • Principal Investigator: Yu Shi, Sichuan Cancer Hospital and Research Institute
  • Principal Investigator: Hong Liu, Sichuan Cancer Hospital and Research Institute
  • Principal Investigator: Dengfeng Wang, Sichuan Cancer Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Actual)

September 2, 2017

Study Completion (Actual)

March 21, 2018

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SichuanCHRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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