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Completed

NCT Number: NCT03629626

Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Cancer Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, China

About this study

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 and <70 years old
  • Patients candidated for elective gynecological surgery for benign pathology
  • Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
  • Signed consent form

Exclusion criteria

  • Contraindication to loco-regional anaesthesia
  • Patients with ileus or subocclusive condition prior surgery
  • Coagulation disorders
  • Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
  • Uncontrolled hypertension (>180/95)
  • Alcohol or drug abuser (current or previous)
  • Psychiatric condition or language barriers
  • Planned Intensive Care Recovery

Treatment and study plan

ERAS protocol

Procedure

preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.

It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

Primary outcomes

  1. Shorter Length Of Hospitalization (LOH)

    Time frame: Up to 4 weeks after surgery

    Total amount of days spent in hospital

Secondary outcomes

  1. Assessment of postoperative pain

    Time frame: At moment 24 hours after surgery

    Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.

  2. Presence/Absence of nausea

    Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery

    Treatment for postoperative nausea

  3. Presence/Absence of vomiting

    Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery

    Treatment for postoperative vomiting

  4. Time to flatus

    Time frame: Up to 4 weeks after surgery

    Hours elapsed to event

  5. Time to bowel movement

    Time frame: Up to 4 weeks after surgery

    Hours elapsed to event

  6. Foley catheter removal

    Time frame: From 1 to 14days post surgery

    Time to Foley catheter removal postoperative

  7. Time to drink

    Time frame: Up to 4 weeks after surgery

    Hours elapsed to event

  8. Time to eating

    Time frame: Up to 4 weeks after surgery

    Hours elapsed to event

  9. Time to walking

    Time frame: Up to 4 weeks after surgery

    Hours elapsed to event

  10. Postoperative complications

    Time frame: Up to 2 weeks after surgery

    Rate measurement

  11. Time to adjuvant treatment

    Time frame: 60 days

    Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)

  12. Readmission rates

    Time frame: Up to 21 days post surgery

    Readmissions to the hospital

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

Acronym: ERAS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2018
Registry last updated
Apr 25, 2023

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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