Enhanced Recovery After Surgery Gynecology Oncology
ERAS
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
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
July 11, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 2, 2023
October 1, 2023
3.3 years
July 11, 2016
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total length of hospital stay (days)
total length of hospital stay (days)
Up to 10 days
Secondary Outcomes (9)
Achievement of Postoperative Milestones
30 days
Surgical complications
30 days
Readmission rates
2 week and 30 day
Time to adjuvant treatment
60 days
30-day mortality rates
30 days
- +4 more secondary outcomes
Study Arms (2)
No Intervention Conventional Strategy
NO INTERVENTIONPerioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant.
ERAS Group
EXPERIMENTALERAS (enhanced recovery after surgery)
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prentice Women's Hospital
Chicago, Illinois, 60611, United States
Related Publications (8)
Tewari KS, Java JJ, Eskander RN, Monk BJ, Burger RA. Early initiation of chemotherapy following complete resection of advanced ovarian cancer associated with improved survival: NRG Oncology/Gynecologic Oncology Group study. Ann Oncol. 2016 Jan;27(1):114-21. doi: 10.1093/annonc/mdv500. Epub 2015 Oct 20.
PMID: 26487588BACKGROUNDKehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
PMID: 12095591BACKGROUNDKehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
PMID: 18650627BACKGROUNDGreco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.
PMID: 24368573BACKGROUNDLu D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer patients. Cochrane Database Syst Rev. 2015 Mar 19;2015(3):CD008239. doi: 10.1002/14651858.CD008239.pub4.
PMID: 25789452BACKGROUNDNelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.
PMID: 25316179BACKGROUNDWijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.
PMID: 24828471BACKGROUNDChau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
PMID: 35289396DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Shireen Ahmad, MD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
August 12, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2021
Last Updated
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share