Back to resultsEnhanced Recovery After Surgery in Extremity Sarcoma
Primary Purpose
Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Recovery After Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring Enhanced Recovery After Surgery
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ERAS
Non-ERAS (Conventional)
Arm Description
Administration of a perioperative non-narcotic, multimodal pain management pathway.
Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.
Outcomes
Primary Outcome Measures
Pain scores
Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
Pain scores
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)
Limb function
Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Clinical outcomes - length of hospital stay
Measured by the number of days in the hospital
Clinical outcomes - opioid requirements
Measured by the amount of opioids consumed
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
Measured by the number of perioperative complications reported
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04461171
Brief Title
Enhanced Recovery After Surgery in Extremity Sarcoma
Official Title
Enhanced Recovery After Surgery in Extremity Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Lawrenz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Enhanced Recovery After Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ERAS
Arm Type
Experimental
Arm Description
Administration of a perioperative non-narcotic, multimodal pain management pathway.
Arm Title
Non-ERAS (Conventional)
Arm Type
No Intervention
Arm Description
Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.
Intervention Type
Procedure
Intervention Name(s)
Enhanced Recovery After Surgery
Intervention Description
Undergo an enhanced recovery after surgery program
Primary Outcome Measure Information:
Title
Pain scores
Description
Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
Time Frame
3 months
Title
Pain scores
Description
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)
Time Frame
3 months
Title
Limb function
Description
Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Time Frame
3 months
Title
Clinical outcomes - length of hospital stay
Description
Measured by the number of days in the hospital
Time Frame
3 months
Title
Clinical outcomes - opioid requirements
Description
Measured by the amount of opioids consumed
Time Frame
3 months
Title
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
Description
Measured by the number of perioperative complications reported
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Lawrenz, MD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
First Name & Middle Initial & Last Name & Degree
Joshua M Lawrenz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhanced Recovery After Surgery in Extremity Sarcoma
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