Enhanced Recovery After Spine Surgery

NCT ID: NCT02949518

Last Updated: 2020-07-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2020-05-31

Brief Summary

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Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.

Detailed Description

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Conditions

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Enhanced Recovery After Surgery Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Enhanced Recovery Pathway for Spine

Group Type EXPERIMENTAL

Enhanced Recovery Pathway (ERP) for Spine

Intervention Type OTHER

The study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Recovery Pathway (ERP) for Spine

The study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any patient presenting for 1 or 2 level posterior lumbar fusion.

Exclusion Criteria

* Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).
* Kidney disease: GFR \<60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).
* Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.
* Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).
* Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.
* Patients whose primary or preferred language is not English.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen Soffin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, NY

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-617

Identifier Type: -

Identifier Source: org_study_id

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