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Completed

NCT Number: NCT02687412

Fast-track Surgery After Gynecological Oncology 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.

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Key information

Conditions

Length of Stay CRP Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

LinShuangfeng

Leshan, Sichuan, 610000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

pre-operative assessment, counseling and education

Procedure

pre-operative assessment, counseling and FT management education

Preoperative nutritional drink up to 4 h prior to surgery

Procedure

Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used

bowel preparation

Procedure

patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool

preoperative treatment with carbohydrates

Procedure

preoperative treatment with carbohydrates (patients without diabetes).

fast solid

Procedure

fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;

avoiding hypothermia

Procedure

avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

Postoperative glycaemic control

Procedure

Postoperative glycaemic control;

postoperative nausea and vomiting (PONV) control;

Procedure

early postoperative diet

Procedure

early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

pre-operative fasting at least 8h

Procedure

bowel preparation for traditional surgery

Procedure

Oral bowel preparations or mechanical bowl until liquid stool

began to take solid diet after anal exhaust

Procedure

6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

Primary outcomes

  1. Length of Hospitalization Post-operation

    Time frame: up to 12 months

    days from operation date to discharge date

  2. The Total Cost (RMB)

    Time frame: 12 month

    The total cost from hospitalization

Secondary outcomes

  1. CRP

    Time frame: up to 12 months

    C-Reactive protein mg/L

  2. 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.

  3. Number of Participants With Infection,

    Time frame: up to 12 months

    infection(wound infection, lung infection, intraperitoneal infection, operation space infection)

  4. 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

  5. Number of Participants With Ileus

    Time frame: up to 12 months

    is a disruption of the normal propulsive ability of the gastrointestinal tract

  6. Number of Participants With Postoperative Haemorrhage

    Time frame: up to 12 months

    Evidence of blood loss from drains or based on ultrasonography

  7. Number of Participants With Postoperative Thrombosis

    Time frame: up to 12 months

    Evidence of blood thrombosis of participants after surgery

  8. PCT Calcitonin Postoperative

    Time frame: 12 month

    value of calcitonin postoperative

  9. Cost of Surgical Therapy

    Time frame: 12 month

    Cost of surgical therapy (RMB)

Sponsors and collaborators

Lead sponsor

Ling Cui

Other

Registry information

Official study title

Fast-track Surgery After Gynaecological Oncological Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 22, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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