Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?

NCT ID: NCT04388917

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. In this study, we determined whether the use of hemostatic clips during the tumor resection step reduced blood loss during robot-assisted partial nephrectomy. Methods: In this retrospective study, we included all consecutive patients who underwent RAPN in our university hospital from 2017 to 2019. Three experienced surgeons performed the surgery. One surgeon used Hemo-lock hemostatic clips during tumor resection to prevent bleeding, and two did not. Blood loss in the two groups was compared as the primary endpoint. The duration of clamping, operative time, complications, surgical margins, transfusions, serum creatinine and hemoglobin were compared as secondary endpoints. Results: 53 patients were included, 36 in the No-clip group and 17 in the Clip group. Our two groups were comparable for age, weight, Charlson score, tumor size and RENAL score. There was a significant difference between the two groups for median blood loss 50 mL in the Clip group versus 300 mL in the No-clip group (p = 0.0001), whereas median operating time was shorter in the No-clip group, 140 min versus 180 min for the Clip group (p = 0.044). No other criterion showed a significant difference. The use of Hemo-lock during the tumor resection step in RAPN reduced blood loss without impairing renal function. Larger studies are still needed to confirm our findings.

Detailed Description

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Conditions

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Renal Cancer Kidney Cancer Blood Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Clip Group

Use of Hemo-lock hemostatic clips during tumor resection to prevent bleeding

Patial nephrectomy

Intervention Type PROCEDURE

Partial nephrectomy assisted with robot to remove kidney cancer

No Clip group

No Hemo-lock hemostatic clips used during tumor resection

Patial nephrectomy

Intervention Type PROCEDURE

Partial nephrectomy assisted with robot to remove kidney cancer

Interventions

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Patial nephrectomy

Partial nephrectomy assisted with robot to remove kidney cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Exclusion Criteria

* patient off clamping or partial clamping
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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20Urobase02

Identifier Type: -

Identifier Source: org_study_id

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