Enhanced Recovery After Surgery for SPK Transplantation Recipients

Study Overview
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Brief Summary
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108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.

Detailed Description
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Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.

Official Title
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A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation

Conditions
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Transplant Complication, Diabetic Nephropathy, Perioperative/Postoperative Complications

Intervention / Treatment
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* Procedure: Enhanced recovery for SPK recipients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were aged 20-62 years Body mass index (BMI) of 18.5-32.9 kg/m2 Voluntary participation for elective SPK surgery ERSD and DN patients waiting for SPK transplantation surgery. Exclusion Criteria: History of allergy to narcotic drugs cardiopulmonary insufficiency congestive heart failure myasthenia gravis neurological disease mental illness severe liver dysfunction hyperkalaemia malignant hyperthermia unwilling to participate in the study for any reason, or had participated in another study within the 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled tiral
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>ERAS group was consisted of evidenced-based systematic optimization approaches | Procedure: Enhanced recovery for SPK recipients<br>* Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.<br>|
| No Intervention: Traditional group<br>The control group received routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (LoS) | Record the time for SPK recipients of LoS (days) | Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days). | 
| Hospital costs (US dollar) | The total cost of treatment for the patients. | Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | 48 hours post-operative analgesia score (NRS), the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days | After the surgery acomplishment(see detail above)：record the NRS within 40hours after the surgery, occurrence rate of the PPCs within 2 weeks after the surgery, ocurrence rate of the ambulation within 6 days after the surgery, etc. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery, SPK transplantation