Enhanced Recovery After Surgery in Extremity Sarcoma

NCT ID: NCT04461171

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.

Detailed Description

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Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores \[PROMIS\] and \[QoR-15\]), limb function scores \[MSTS\], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).

Conditions

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Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS

Administration of a perioperative non-narcotic, multimodal pain management pathway.

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery

Intervention Type PROCEDURE

Undergo an enhanced recovery after surgery program

Non-ERAS (Conventional)

Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Recovery After Surgery

Undergo an enhanced recovery after surgery program

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
* Adult patients \>17 years of age
* Patients of all preoperative opioid status (naïve or dependent)

Exclusion Criteria

* Patients treated non-operatively
* Non-English speaking patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joshua Lawrenz

OTHER

Sponsor Role lead

Responsible Party

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Joshua Lawrenz

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joshua Lawrenz, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vanderbilt-Ingram Service for Timely Access

Role: CONTACT

800-811-8480

Facility Contacts

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Vanderbilt-Ingram Service for Timely Access

Role: primary

800-811-8480

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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VICC SAR 2020

Identifier Type: -

Identifier Source: org_study_id

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