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Trial Title:
Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy
NCT ID:
NCT06322745
Condition:
Renal Tumor
Renal Malignant Tumor
Conditions: Official terms:
Neoplasms
Carcinoma, Renal Cell
Hemostatics
Conditions: Keywords:
Thulium laser
Laparoscopic partial nephrectomy
Ischemia time
Small renal mass
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A randomized prospective comparative study. Two-arm parallel assignment:
First Arm: involves cases of laparoscopic partial nephrectomy done with suture
renorrhaphy only for hemostasis of the tumor bed.
Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam
coagulation and suture renorrhaphy for hemostasis of the tumor bed.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy
Description:
Suture renorrhaphy will be used in 2 layers; medullary and cortical, with Vicry 2/0 or
3/0 and secured with V-lock. Early unclamping will be done after hemostasis of the
medullary layer. Renorrhaphy of the cortical layer will be continued after that.
Arm group label:
suture renorrhaphy group
Intervention type:
Procedure
Intervention name:
Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy
Description:
A 2-μm continuous thulium laser with 365 μm laser fiber at 30-40 W will be used for
coagulation of the tumor bed. Large vessels that may not be completely sealed with
thulium beam will be closed by V-lock to achieve safe and stable hemostasis. Early
unclamping will be done after hemostasis of the tumor bed. Suture renorrhaphy will be
used in 1 layer to approximate the renal parenchyma.
Arm group label:
thulium beam coagulation group
Summary:
To compare the outcome of thulium beam coagulation versus suture renorrhaphy for
hemostasis of the tumor bed in laparoscopic partial nephrectomy.
Detailed description:
To date, no studies have compared the outcomes of thulium beam coagulation versus suture
renorrhaphy for hemostasis of tumor bed in laparoscopic partial nephrectomy in patients
with small renal messes (SRMs).
This study aims to compare the outcome of thulium beam coagulation versus suture
renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
The investigators hypothesize that:
Conducted well designed, randomized prospective comparative study can help to identify
which technique is better.
Using thulium beam coagulation for hemostasis of the tumor bed in laparoscopic partial
nephrectomy can improve the outcome, shorten intraoperative ischemia time and decrease
blood loss.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- cT1 single renal mass.
Exclusion Criteria:
1. Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary
insufficiency, and chronic obstructive lung disease).
2. Renal mass involving the hilum.
3. Renal mass in patients with chronic kidney disease.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Department, Al-Azhar University Hospitals
Address:
City:
Cairo
Zip:
11511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Malakah Mohammed, Secretary
Phone:
+20225107222
Email:
urologydepartment@azhar.edu.eg
Start date:
June 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Al-Azhar University
Agency class:
Other
Source:
Al-Azhar University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322745