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Enhanced Recovery After Surgery Gynecology Oncology (ERAS)

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ClinicalTrials.gov Identifier: NCT02864277
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University

Brief Summary:
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 open abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay, without increasing readmission rates. ASD

Condition or disease Intervention/treatment Phase
Malignant Female Reproductive System Neoplasm Procedure: No Intervention Conventional Strategy Procedure: ERAS Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
No Intervention: No Intervention Conventional Strategy
Perioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant.
Experimental: ERAS Group
ERAS (enhanced recovery after surgery)
Procedure: No Intervention Conventional Strategy

The Conventional Strategy Group description encompasses over 4 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.

Preoperative Management Interoperative Management Postoperative Management Post discharge


Procedure: ERAS

The ERAS Group description encompasses over 3 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.

Preoperative Management Interoperative Management Postoperative Management Post discharge





Primary Outcome Measures :
  1. Total length of hospital stay (days) [ Time Frame: Up to 10 days ]
    total length of hospital stay (days)


Secondary Outcome Measures :
  1. Achievement of Postoperative Milestones [ Time Frame: 30 days ]

    Achievement of the below milestones:

    A) Void Freely(Return of Bladder Function) B) Pain Controlled with oral Medications C) Eating Target Diet without emesis D) Passing Flatus (Return of Bowel Function) E) Ambulating at Baseline F) Self Care at Baseline


  2. Surgical complications [ Time Frame: 30 days ]
    Surgical complications within 30 days of procedure

  3. Readmission rates [ Time Frame: 2 week and 30 day ]
    Readmission rates assessed at 2 week and 30 day

  4. Time to adjuvant treatment [ Time Frame: 60 days ]
    Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)

  5. 30-day mortality rates [ Time Frame: 30 days ]
    30-day mortality rates of participants

  6. Patient reported satisfaction [ Time Frame: 14 days ]
    Quality of Recovery 40 questionnaire results from participants

  7. Progression-free survival [ Time Frame: 2 years ]
    Progression-free survival post procedure

  8. Preoperative vs postoperative day # 1 C-Reactive Protein (CRP) [ Time Frame: 24 hours post surgery ]
    Preoperative vs postoperative day #1 C-Reactive Protein (CRP) levels for all participants blood samples.

  9. Preoperative vs postoperative day # 1 Interleukin-6 (IL-6) levels [ Time Frame: 24 hours post surgery ]
    Preoperative vs postoperative day #1 Interleukin-6 (IL-6) levels for all participants blood samples.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between the ages of 18-70 years
  • Fluent in English language
  • Known or suspected diagnosis of gynecologic malignancy (including ovarian, endometrial, and cervical cancers)
  • Scheduled for elective laparotomy
  • Medically eligible for major surgical procedure

Exclusion Criteria:

  • Unable to mobilize independently preoperatively
  • The following populations will not be included in the study: adults unable to consent (such as the cognitively impaired), minors < 18 years of age, pregnant women, and prisoners.
  • Emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864277


Contacts
Contact: Shireen Ahmad, MD 321-471-3585 sah704@northwestern.edu
Contact: Robert McCarthy, PharmD 312-695-4976 r-mccarthy@northwestern.edu

Locations
United States, Illinois
Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Shireen Ahmad, M.D.    312-472-3585    sah704@northwestern.edu   
Contact: Robert McCarthy, PharmD    312-695-4976    r-mccarthy@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Shireen Ahmad, MD Northwestern University

Publications:
Responsible Party: Shireen Ahmad, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02864277     History of Changes
Other Study ID Numbers: STU00203177
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shireen Ahmad, Northwestern University:
Gynecology
Cancer
General Surgery
Recovery Quality
Length of hospital stay

Additional relevant MeSH terms:
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms