Enhanced Recovery After Surgery Gynecology Oncology

Study Overview
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Brief Summary
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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
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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).

Official Title
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Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial

Conditions
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Malignant Female Reproductive System Neoplasm

Intervention / Treatment
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* Procedure: No Intervention Conventional Strategy
* Procedure: ERAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention Conventional Strategy<br>Perioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant. | |
| Experimental: ERAS Group<br>ERAS (enhanced recovery after surgery) | Procedure: No Intervention Conventional Strategy<br>* 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<br>Procedure: ERAS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total length of hospital stay (days) | total length of hospital stay (days) | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Postoperative Milestones | 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 | 30 days | 
| Surgical complications | Surgical complications within 30 days of procedure | 30 days | 
| Readmission rates | Readmission rates assessed at 2 week and 30 day | 2 week and 30 day | 
| Time to adjuvant treatment | Time participant receives adjuvant treatment, if needed (chemotherapy or radiation) | 60 days | 
| 30-day mortality rates | 30-day mortality rates of participants | 30 days | 
| Patient reported satisfaction | Quality of Recovery 40 questionnaire results from participants | 14 days | 
| Progression-free survival | Progression-free survival post procedure | 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. | 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. | 24 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecology, Cancer, General Surgery, Recovery Quality, Length of hospital stay