NCT03629626

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

August 10, 2018

Last Update Submit

April 22, 2023

Conditions

Gynecologic DiseaseGynecologic Cancer

Keywords

preoperative / intraoperative/ postoperative management

Outcome Measures

Primary Outcomes (1)

  • Shorter Length Of Hospitalization (LOH)

    Total amount of days spent in hospital

    Up to 4 weeks after surgery

Secondary Outcomes (12)

  • Assessment of postoperative pain

    At moment 24 hours after surgery

  • Presence/Absence of nausea

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

  • Presence/Absence of vomiting

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

  • Time to flatus

    Up to 4 weeks after surgery

  • Time to bowel movement

    Up to 4 weeks after surgery

  • +7 more secondary outcomes

Study Arms (2)

Conventional Perioperative (SP) care

NO INTERVENTION

Conventional Perioperative (SP) care

ERAS protocol

EXPERIMENTAL

preoperative / intraoperative/ postoperative management

Procedure: ERAS protocol

Interventions

ERAS protocolPROCEDURE

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.

ERAS protocol

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Related Publications (2)

  • Xing N, Wang H, Huang Y, Peng J. Enhanced recovery after surgery program alleviates neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients undergoing gynecological surgery. Front Med (Lausanne). 2023 Apr 17;10:1057923. doi: 10.3389/fmed.2023.1057923. eCollection 2023.

    PMID: 37138751DERIVED

  • Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.

    PMID: 34103993DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Beihua Kong, MD.PhD.

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 14, 2018

Study Start

August 15, 2018

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(1)