Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Total length of hospital stay (days)
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Total length of hospital stay (days)
Time Frame: Up to 10 days
total length of hospital stay (days)
Secondary Outcomes
- Readmission rates(2 week and 30 day)
- Patient reported satisfaction(14 days)
- Progression-free survival(2 years)
- Preoperative vs postoperative day # 1 C-Reactive Protein (CRP)(24 hours post surgery)
- Achievement of Postoperative Milestones(30 days)
- Surgical complications(30 days)
- 30-day mortality rates(30 days)
- Time to adjuvant treatment(60 days)
- Preoperative vs postoperative day # 1 Interleukin-6 (IL-6) levels(24 hours post surgery)