Enhanced Recovery After Surgery in Kidney Transplant Donors
Recruiting in Palo Alto (17 mi)
Overseen byUzong Yoon, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thomas Jefferson University
No Placebo Group
Trial Summary
What is the purpose of this trial?Enhanced recovery after surgery (ERAS) pathways are designed to optimize perioperative management, improving patient outcomes and satisfaction through multimodal techniques. Living kidney transplant donors are typically healthy individuals who undergo laparoscopic nephrectomy. The most significant hindrance to discharge to return to activities of daily living is frequently return of bowel function and postoperative pain.
Through a randomized controlled trial design, we will evaluate the effectiveness of implementing an ERAS pathway. We hypothesize that preoperative patient optimization through exercise, carbohydrate loading, and counseling on expectations, in addition to multimodal pain management strategies which limit opioids would allow faster recovery, early bowel function, decreased postoperative pain, increased patient satisfaction and shorter length of stay.
The study population will include a total of 42 patients (age 18-80) who are American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3, undergoing living donor nephrectomy. Our primary outcome measures will be postoperative opioid consumption. Secondary outcome measures are: postoperative pain score, time to return of bowel function, ambulation, first oral intake postoperatively, and patient satisfaction scores. Other objectives include reducing readmissions, shorter hospital length of stay and decreased operative complications, including nausea, vomiting and wound infection.
Eligibility Criteria
Inclusion Criteria
All patients who agree to undergo this procedure.
Exclusion Criteria
Female patients who are pregnant or nursing
American Society of Anesthesiology classification greater than 3
You do not want to participate in the study.
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Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced recovery after surgeryExperimental Treatment5 Interventions
Preoperatively, patients will be counseled on optimization of physical and nutritional status. They will receive carbohydrate loading drinks prior to surgery. Intraoperatively, standard ASA monitors will be utilized, and patients will receive general anesthesia. Goal directed fluid management will be enforced with bolus options based on hemodynamics. Transabdominal plane and rectus sheath block will be performed in the operating room by the regional anesthesia team. Post-operatively pain management will include multimodal analgesic medications. Regular diet will be allowed and encouraged on post-operative day 0 (POD). Lines and drains will be minimized to encourage early mobilization and bowel function. Patients will be counseled on expectations of discharge criteria POD0.
Group II: Standard of careActive Control1 Intervention
Patients will receive traditional care for donor nephrectomy. Patients will be instructed to fast for 24 hours preoperative. On day of surgery, standard monitors will be used, and intraoperative management per anesthesiologists discretion including pain management. Post-operative, patients will receive pain medications, including opioids, as needed. Intravenous fluids will be continued until patients tolerate liquids per os. Bowel regimen will be ordered as needed. Patients will be discharged once meeting pre-set criteria.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Thomas Jefferson University HospitalPhiladelphia, PA
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Who Is Running the Clinical Trial?
Thomas Jefferson UniversityLead Sponsor