Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in renal functional reserve after laparoscopic deroofing
Study Overview
Brief Summary
Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.
Detailed Description
Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Estimated GFR >30 mL/min/1.73m2
- •Subjects who signed informed consent forms
Exclusion Criteria
- •Allergy to iothalamate, shellfish or iodine
- •Use of metformin or amiodarone
- •Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- •Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- •Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- •Inadequate intravenous access
- •Severe anemia (Hct <21%)
- •Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- •History of contrast-induced nephropathy
- •Hyperthyroidism
- •Pheochromocytoma
- •Sickle cell disease
- •Urinary retention or incontinence
- •Status post organ transplant
- •Pregnancy or active breast feeding
- •Cognitive impairment with inability to give consent
- •Institutionalized status
Arms & Interventions
endophytic group
participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
Intervention: Laparoscopic deroofing (Procedure)
endophytic group
participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
Intervention: 100 g of amino acids supplementation (Drug)
exophytic group
participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
Intervention: Laparoscopic deroofing (Procedure)
exophytic group
participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
Intervention: 100 g of amino acids supplementation (Drug)
Outcomes
Primary Outcomes
Change in renal functional reserve after laparoscopic deroofing
Time Frame: 1 month after surgery.
1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.
Secondary Outcomes
No secondary outcomes reported
Investigators
ou tongwen
Head of Urology
Xuanwu Hospital, Beijing