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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388917
• Other study ID #: 20Urobase02
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Exclusion Criteria:

• patient off clamping or partial clamping

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Kidney Cancer
• Kidney Neoplasms
• Renal Cancer

Intervention

Procedure:
• Patial nephrectomy
Partial nephrectomy assisted with robot to remove kidney cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss in the two groups was compared	It was mesured during the surgery by amount of blood drawn	3 years
Secondary	operative time	duration from the begining to the end of the surgery	3 years
Secondary	duration of clamping	time between the clips set and remove during the surgery for patient of clip group	3 years
Secondary	incidence of complications	rate of complication after surgery	3 years