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Enhanced Recovery After Surgery in Kidney Transplant Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110080
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Opioid Use Kidney Diseases Pain, Postoperative Postoperative Complications Postoperative Nausea and Vomiting Procedure: multimodal pain management Other: goal directed fluid management Other: preoperative carbohydrate loading Procedure: Donor nephrectomy Procedure: regional anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery in Living Donor Kidney Transplant Donors
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : September 12, 2021
Estimated Study Completion Date : September 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced recovery after surgery
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.
Procedure: multimodal pain management
Regional anesthesia techniques, specifically rectus sheath and transabdominal plane blocks, for pain management will be performed.

Other: goal directed fluid management
Intraoperatively fluids will be administered based on hemodynamic parameters, in addition to clinical judgement.

Other: preoperative carbohydrate loading
Patient's nutrition will be optimized preoperatively by administering carbohydrate drinks, and limiting fasting time.

Procedure: Donor nephrectomy
All patient will have laparoscopic nephrectomy procedure with transplant surgery.

Procedure: regional anesthesia
transabdominal plane and rectus sheath nerve block

Active Comparator: Standard of care
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.
Procedure: Donor nephrectomy
All patient will have laparoscopic nephrectomy procedure with transplant surgery.




Primary Outcome Measures :
  1. post operative opioid consumption [ Time Frame: from time after discharge from PACU to discharge from the hospital (up to 7 days) ]
    amount of opioid pain medication required post operatively


Secondary Outcome Measures :
  1. duration of hospitalization [ Time Frame: from arrival on day of surgery to discharge from hospital (up to 7 days, anticipated 3 days) ]
    Hospital length of stay from day of surgery to discharge.

  2. time to return of bowel function [ Time Frame: arrival to PACU until discharge from hospital (up to 7 days) ]
    Post operative time to first sign of bowel function, either flatus or bowel movement.

  3. time to first oral intake [ Time Frame: from arrival to PACU until post-operative day 2 (48 hours) ]
    Post operative time following surgery until patient takes liquid/solid per os.

  4. patient satisfaction [ Time Frame: from discharge from PACU post operative day one to discharge home on last day of hospitalization (up to 7 days) ]
    Patient experience survey will be administered on last day of hospitalization. 14 question survery adapted from Cabellos M, et. al. Member of research team will distribute survey for completion by patients on last day of surgery. Survey focuses on pain management, communiation, recovery progression, facilities, and overall experience. Selection of open answer and likert scale questions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients undergoing this procedure who consent

Exclusion Criteria:

  • patient refusal, female patients who are pregnant or nursing, patients with allergy to local anesthetic, American Society of Anesthesiology classification greater than 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110080


Contacts
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Contact: Natalie Neiswinter, MD 7176794438 natalie.neiswinter@jefferson.edu
Contact: Uzong Yoon, MD, MPH 215-955-6161 uzung.yoon@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Natalie R Neiswinter, MD    717-679-4438    natalie.neiswinter@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Uzong Yoon, MD, MPH Thomas Jefferson University
Publications:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04110080    
Other Study ID Numbers: 19D.574
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
enhanced recovery after surgery
living donor kidney transplant
multimodal analgesia
Additional relevant MeSH terms:
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Kidney Diseases
Vomiting
Pain, Postoperative
Postoperative Complications
Postoperative Nausea and Vomiting
Urologic Diseases
Nausea
Signs and Symptoms, Digestive
Pathologic Processes
Pain
Neurologic Manifestations
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs