(P 404) ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL FOR PATENTS WITH SOFT TISSUE SARCOMA OF THE EXTREMITY: A PROSPECTIVE, NON-RANDOMIZED, CONSECUTIVELY ENROLLED TRIAL

Objective: Patients undergoing extremity soft tissue sarcoma resection have high morbidity rates, including wound complications, infections, and post-operative pain. Though enhanced recovery after surgery (ERAS) programs have shown improved outcomes in other types of cancer surgery, studies in extremity sarcoma are few; to date, there has yet to be any published assessment of opiate consumption, effect of nutritional supplementation, and patient reported or functional outcomes. This prospective, non-randomized, consecutively enrolled trial aims to determine if an ERAS program can reduce the morbidity associated with the resection of extremity soft tissue sarcoma.

Methods: An ERAS pathway was implemented at our high-volume sarcoma center in 2022. This pathway is centered around five key components of care: 1) pre- and post-operative nutritional supplementation; 2) pre-operative optimization of co-morbidities through a specialized anesthesia screening clinic; 3) utilization of non-narcotic, multimodal, and regional analgesia; 4) implementation of early mobilization with physical therapy; and 5) perioperative and postoperative antibiotics (Figure 1). Oral immunonutrition is consumed 7 days before surgery, during admission, and 3 days after surgery. Pre- and post-operative nutrition lab markers are drawn, and deficiencies are corrected by the surgical and anesthesia teams. Perioperative intravenous antibiotics include metronidazole in addition to cefazolin, for anaerobic bacteria coverage, based on recently published data.

The primary endpoint of the study is opiate consumption, as measured by oral morphine equivalents (OME). Secondary endpoints include length of stay, readmission, wound complication and infection rates, pain control, and functional (MSTS score) and patient reported outcome measures (TESS and PROMIS scores) (Table 1). An a priori power analysis was conducted to determine the minimum sample size required to test the study hypothesis that the ERAS protocol will decrease OME by 30%. The minimum sample size needed to assess this effect size with 80% power was calculated to be N=48 (α=0.1, =0.2). Assuming a 20% dropout rate, we elected to obtain a sample size of N=60 per arm.

In 2021, the non-ERAS arm (arm 1) enrolled 60 consecutive patients before the initiation of the ERAS pathway in which we provided standard of care and captured primary and secondary outcomes. We are currently enrolling an additional 60 consecutive patients following the implementation of this ERAS pathway (arm 2). To date, we have enrolled 32 patients in arm 2. Our expected trial completion date is May 2025.

Results: N/A - Trials in Progress

Conclusion: N/A - Trials in Progress