Enhanced Recovery After Surgery Gynecology Oncology
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 9/14/2017 |
| Start Date: | August 2016 |
| End Date: | December 2021 |
| Contact: | Shireen Ahmad, MD |
| Email: | sah704@northwestern.edu |
| Phone: | 321-471-3585 |
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
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
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).
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).
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
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