Off Clamp Randomization

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-12-31

Brief Summary

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The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.

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Detailed Description

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Conditions

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Renal Cancer Renal Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Off-clamp partial nephrectomy

Partial nephrectomy will be performed without clamping of the renal blood vessels.

Group Type EXPERIMENTAL

Off-clamp partial nephrectomy

Intervention Type PROCEDURE

Traditional partial nephrectomy

Partial nephrectomy will be performed with clamping of the renal blood vessels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Off-clamp partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients 18 and older.
* Patients willing and able to sign consent.
* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.

Exclusion Criteria

* Patients under 18.
* Patients with Karnofsky Performance Status (KPS) less than 40.
* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
* Patients with bilateral synchronous renal masses.
* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No