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

Completed

• Conditions: Blood Loss; Renal Cancer; Kidney Cancer
• Interventions: Procedure: Patial nephrectomy

• Registration Number: NCT04388917
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Exclusion Criteria

• patient off clamping or partial clamping

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Clip group	Patial nephrectomy	No Hemo-lock hemostatic clips used during tumor resection
Clip Group	Patial nephrectomy	Use of Hemo-lock hemostatic clips during tumor resection to prevent bleeding

Primary Outcome Measures

Name	Time	Method
Blood loss in the two groups was compared	3 years	It was mesured during the surgery by amount of blood drawn

Secondary Outcome Measures

Name	Time	Method
operative time	3 years	duration from the begining to the end of the surgery
duration of clamping	3 years	time between the clips set and remove during the surgery for patient of clip group
incidence of complications	3 years	rate of complication after surgery