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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

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