Malignant Female Reproductive System NeoplasmERASNCT02864277
Enhanced Recovery After Surgery Gynecology Oncology
A study testing ERAS in people with Malignant Female Reproductive System Neoplasm, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial
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
Read the detailed description
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. All patients with a known or suspected gynecologic malignancy scheduled for open abdominal surgery from the gynecologic oncology clinic will be screened for study eligibility. Those eligible for the study will be approached for participation in the study and provided written informed consent.
Once enrolled, study participants will be randomized into two arms (control group and ERAS group) using block randomization (block size=6). Block randomization will be performed using an online randomization generator that can be accessed at http://www.sealed envelope.com/simple randomizer /v1/lists . Due to the requirement for active patient and provider participation, it will not be possible to perform the study with blinded participants and care providers. Study investigators responsible for data collection and outcomes assessment will be blinded to randomization assignments. Once randomized, patients will be seen in preoperative clinic and given specific preoperative instructions as dictated by their study group.
On the day of surgery, patients will receive perioperative care as per protocol, based on their assigned group.
During postoperative care, patients will be asked to fill out a daily diary to document their recovery progress, where they will assess their ability to meet the study milestones, as noted above (e.g. pain and ambulation).
Patients will be eligible for discharge once meeting all pre-defined discharge criteria, including: tolerating oral fluid and diet, pain controlled with oral pain regimen, have return of bowel function (flatus), are self-caring (able to dress, shower, and groom themselves), and are mobilizing independently. Assessment of these parameters will be made by gynecologic oncology clinicians.
After discharge, patients will follow-up in gynecologic oncology clinic at 2 weeks and 6 weeks postoperatively.
Both arms of the study will be protocol-driven, with checklists for patients, nursing staff, and house staff to help with compliance. Teaching sessions and dry runs will be held before trial commencement to clarify points of confusion and to reduce protocol violations.
Data collection on subjects will be performed throughout the duration of their enrollment in the study. Data will be abstracted for medical record charts from Enterprise Data Warehouse and corroborated with Power chart (Northwestern Memorial Hospital), EPIC (Northwestern Memorial Hospital Medical record system), and Surginet (Northwestern Memorial Hospital Surgical Medical Record System).
In addition to the demographic and clinical information that will be abstracted from the medical record, subjects will also complete a validated Quality of Recovery Survey (the QOR (Quality of Recovery-40 question survey) at 2 weeks post-surgery. Lastly, C-Reactive Protein (CRP) and Interleukin-6 (IL-6) levels will be determined from blood collected pre-operatively (to coincide with scheduled pre-operative clinic visit) and on post-operative day 1 (POD#1 (post operative day )], to coincide with scheduled POD#1 blood draw). Blood samples will be collected in provided, 10ml red topped vacuum collection tubes (no anti-coagulant). After collection of the whole blood, the blood will be allowed to clot by leaving it undisturbed at room temperature for 30 minutes. Clot will be removed by centrifugation at 2,000 x g for 10 minutes in a 4°C refrigerated centrifuge. Using a Pasteur pipette the liquid supernatant (serum) will be immediately transferred to collection tube and apportioned into 0.5 ml aliquots and frozen in liquid nitrogen. Samples will be batch processed for CRP and IL-6 levels by ELISA according to manufacturer instructions (affymetrix eBioscience Catalog Numbers: 88-7502 and 88-7066).
- Being tested
- No Intervention Conventional Strategy, ERAS
- Keywords
- Gynecology, Cancer, General Surgery, Recovery Quality, Length of hospital stay
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention Conventional StrategyProcedure or surgery
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
ERASProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| No Intervention Conventional Strategy | No intervention | Perioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant. |
| ERAS Group | Experimental | ERAS (enhanced recovery after surgery) Receives: Procedure: No Intervention Conventional Strategy; Procedure: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of hospital stay (days)
total length of hospital stay (days)
Measured: Up to 10 days
Secondary outcomes (9)
Achievement of Postoperative Milestones
Achievement of the below milestones:
- 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
Measured: 30 days
Surgical complications
Surgical complications within 30 days of procedure
Measured: 30 days
Readmission rates
Readmission rates assessed at 2 week and 30 day
Measured: 2 week and 30 day
Time to adjuvant treatment
Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)
Measured: 60 days
30-day mortality rates
30-day mortality rates of participants
Measured: 30 days
Patient reported satisfaction
Quality of Recovery 40 questionnaire results from participants
Measured: 14 days
Progression-free survival
Progression-free survival post procedure
Measured: 2 years
Preoperative vs postoperative day # 1 C-Reactive Protein (CRP)
Preoperative vs postoperative day #1 C-Reactive Protein (CRP) levels for all participants blood samples.
Measured: 24 hours post surgery
Preoperative vs postoperative day # 1 Interleukin-6 (IL-6) levels
Preoperative vs postoperative day #1 Interleukin-6 (IL-6) levels for all participants blood samples.
Measured: 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shireen Ahmad, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864277
- Sponsor's protocol ID
- STU00203177
- Acronym
- ERAS
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2016
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26487588Kehlet 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.
PubMed 12095591Kehlet 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.
PubMed 18650627Greco 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.
PubMed 24368573Lu 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.
PubMed 25789452Nelson 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.
PubMed 25316179Wijk 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.
PubMed 24828471Chau 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.
PubMed 35289396
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02864277
- Acronym / sponsor ID
- ERAS / STU00203177
- Keywords
- Gynecology, Cancer, General Surgery, Recovery Quality, Length of hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. All patients with a known or suspected gynecologic malignancy scheduled for open abdominal surgery from the gynecologic oncology clinic will be screened for study eligibility. Those eligible for the study will be approached for participation in the study and provided written informed consent.
Once enrolled, study participants will be randomized into two arms (control group and ERAS group) using block randomization (block size=6). Block randomization will be performed using an online randomization generator that can be accessed at http://www.sealed envelope.com/simple randomizer /v1/lists . Due to the requirement for active patient and provider participation, it will not be possible to perform the study with blinded participants and care providers. Study investigators responsible for data collection and outcomes assessment will be blinded to randomization assignments. Once randomized, patients will be seen in preoperative clinic and given specific preoperative instructions as dictated by their study group.
On the day of surgery, patients will receive perioperative care as per protocol, based on their assigned group.
During postoperative care, patients will be asked to fill out a daily diary to document their recovery progress, where they will assess their ability to meet the study milestones, as noted above (e.g. pain and ambulation).
Patients will be eligible for discharge once meeting all pre-defined discharge criteria, including: tolerating oral fluid and diet, pain controlled with oral pain regimen, have return of bowel function (flatus), are self-caring (able to dress, shower, and groom themselves), and are mobilizing independently. Assessment of these parameters will be made by gynecologic oncology clinicians.
After discharge, patients will follow-up in gynecologic oncology clinic at 2 weeks and 6 weeks postoperatively.
Both arms of the study will be protocol-driven, with checklists for patients, nursing staff, and house staff to help with compliance. Teaching sessions and dry runs will be held before trial commencement to clarify points of confusion and to reduce protocol violations.
Data collection on subjects will be performed throughout the duration of their enrollment in the study. Data will be abstracted for medical record charts from Enterprise Data Warehouse and corroborated with Power chart (Northwestern Memorial Hospital), EPIC (Northwestern Memorial Hospital Medical record system), and Surginet (Northwestern Memorial Hospital Surgical Medical Record System).
In addition to the demographic and clinical information that will be abstracted from the medical record, subjects will also complete a validated Quality of Recovery Survey (the QOR (Quality of Recovery-40 question survey) at 2 weeks post-surgery. Lastly, C-Reactive Protein (CRP) and Interleukin-6 (IL-6) levels will be determined from blood collected pre-operatively (to coincide with scheduled pre-operative clinic visit) and on post-operative day 1 (POD#1 (post operative day )], to coincide with scheduled POD#1 blood draw). Blood samples will be collected in provided, 10ml red topped vacuum collection tubes (no anti-coagulant). After collection of the whole blood, the blood will be allowed to clot by leaving it undisturbed at room temperature for 30 minutes. Clot will be removed by centrifugation at 2,000 x g for 10 minutes in a 4°C refrigerated centrifuge. Using a Pasteur pipette the liquid supernatant (serum) will be immediately transferred to collection tube and apportioned into 0.5 ml aliquots and frozen in liquid nitrogen. Samples will be batch processed for CRP and IL-6 levels by ELISA according to manufacturer instructions (affymetrix eBioscience Catalog Numbers: 88-7502 and 88-7066).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention Conventional Strategy | No intervention | –Perioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant. |
| ERAS Group | Experimental | Procedure: No Intervention Conventional Strategy, Procedure: ERASERAS (enhanced recovery after surgery) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention Conventional StrategyThe 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 or surgery | ERAS Group |
| ERASThe 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 | Procedure or surgery | ERAS Group |
Primary outcome
Total length of hospital stay (days)
Time frame: Up to 10 days
total length of hospital stay (days)
9 secondary outcomes
Achievement of Postoperative Milestones
Time frame: 30 days
Surgical complications
Time frame: 30 days
Readmission rates
Time frame: 2 week and 30 day
Time to adjuvant treatment
Time frame: 60 days
30-day mortality rates
Time frame: 30 days
Patient reported satisfaction
Time frame: 14 days
Progression-free survival
Time frame: 2 years
Preoperative vs postoperative day # 1 C-Reactive Protein (CRP)
Time frame: 24 hours post surgery
Preoperative vs postoperative day # 1 Interleukin-6 (IL-6) levels
Time frame: 24 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 26487588Tewari 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.
- Background: PubMed 12095591Kehlet 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.
- Background: PubMed 18650627Kehlet 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.
- Background: PubMed 24368573Greco 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.
- Background: PubMed 25789452Lu 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.
- Background: PubMed 25316179Nelson 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.
- Background: PubMed 24828471Wijk 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.
- Derived from this study: PubMed 35289396Chau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shireen Ahmad, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with Malignant Female Reproductive System Neoplasm, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of hospital stay (days) (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02864277, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.