Enhanced Recovery After Surgery Gynecology Oncology
Condition: Malignant Female Reproductive System Neoplasm
MeSH terms: Genital Neoplasms, Female
Study type: Interventional

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.

      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).
    

Intervention name(s): No Intervention Conventional Strategy; ERAS
Intervention type(s): Procedure; Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gynecology; Cancer; General Surgery; Recovery Quality; Length of hospital stay