Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing

NCT03259594 | Unknown

• 1 other identifier: otw-20170804-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.

Conditions

Simple Renal Cyst

Keywords

Renal functional reserve; Simple renal cysts; Laparoscopic deroofing

Outcome Measures

Primary Outcomes (1)

• Change in renal functional reserve after laparoscopic deroofing

  1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

  1 month after surgery.

Study Arms (2)

endophytic group

EXPERIMENTAL

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.

Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation

exophytic group

SHAM COMPARATOR

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.

Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation

Interventions

Laparoscopic deroofing PROCEDURE

The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.

endophytic group; exophytic group

100 g of amino acids supplementation DRUG

intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.

Also known as: Compound Amino Acids Injection(18AA-Ⅶ)

endophytic group; exophytic group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Estimated GFR \>30 mL/min/1.73m2
• Subjects who signed informed consent forms

You may not qualify if:

• 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

Sponsors & Collaborators

• ou tongwen: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Officials

• Tongwen Ou, MD.

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Zhenhua Shang, MD.

CONTACT

+8617801117318; shangzhenhua16@126.com

Hao Yan, MD.

CONTACT

+8683198448

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Urology

Model Details: Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)