Enhanced Recovery After Surgery Gynecology Oncology

Not Applicable

Completed

• Conditions: Malignant Female Reproductive System Neoplasm
• Interventions: Procedure: No Intervention Conventional Strategy; Procedure: ERAS

• Registration Number: NCT02864277
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study First Submitted: 2016-07-11
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-12
• Primary Completion: 2019-12
• Study Completion: 2021-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS Group	ERAS	ERAS (enhanced recovery after surgery)
ERAS Group	No Intervention Conventional Strategy	ERAS (enhanced recovery after surgery)

Primary Outcome Measures

Name	Time	Method
Total length of hospital stay (days)	Up to 10 days	total length of hospital stay (days)

Secondary Outcome Measures

Name	Time	Method
Readmission rates	2 week and 30 day	Readmission rates assessed at 2 week and 30 day
Patient reported satisfaction	14 days	Quality of Recovery 40 questionnaire results from participants
Progression-free survival	2 years	Progression-free survival post procedure
Preoperative vs postoperative day # 1 C-Reactive Protein (CRP)	24 hours post surgery	Preoperative vs postoperative day #1 C-Reactive Protein (CRP) levels for all participants blood samples.
Achievement of Postoperative Milestones	30 days	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
Surgical complications	30 days	Surgical complications within 30 days of procedure
30-day mortality rates	30 days	30-day mortality rates of participants
Time to adjuvant treatment	60 days	Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)
Preoperative vs postoperative day # 1 Interleukin-6 (IL-6) levels	24 hours post surgery	Preoperative vs postoperative day #1 Interleukin-6 (IL-6) levels for all participants blood samples.

Trial Locations

Locations (1)

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States