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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS | Experimental | Administration of a perioperative non-narcotic, multimodal pain management pathway. |
|
| Non-ERAS (Conventional) | No Intervention | Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery | Procedure | Undergo an enhanced recovery after surgery program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time) | 3 months |
| 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) | 3 months |
| Limb function | Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst) | 3 months |
| Clinical outcomes - length of hospital stay | Measured by the number of days in the hospital | 3 months |
| Clinical outcomes - opioid requirements | Measured by the amount of opioids consumed | 3 months |
| Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission) | Measured by the number of perioperative complications reported | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt-Ingram Service for Timely Access | Contact | 800-811-8480 | cip@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Lawrenz, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2023 | Jul 19, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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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.
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