Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy

Renal Tumor Clinical Trial

Official title:

Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322745
• Other study ID #: 1986
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Al-Azhar University
• Contact: Ehab Atallah, A. Lecturer
• Phone: 00201009661125
• Email: Ehab44ehab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Neoplasms
• Renal Malignant Tumor
• Renal Tumor

Intervention

Procedure:
• Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy
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.
• Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy
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.

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).	Started once renal artery clamped before tumor enucleation till release of the clamp after 1st layer renorraphy in group 1 or Thulium beam coagulation in group 2	during the surgery
Primary	Suture time and operative time in minutes	Suture time starts from the first suture to the last one, including time of manipulating needles.	during the surgery
Primary	Intraoperative number of sutures for renorraphy	which is the count of each time the needle comes out from the renal parenchyma.	during the surgery
Primary	Intraoperative Blood loss	Blood loss will be calculated from the suction jar minus the amount of fluid irrigation	during the surgery
Primary	Blood transfusion rate	Amount of blood in ml transfused intraoperative or postoperative	perioperatively
Primary	Renal function: serum creatinine	will be estimated by serum creatinine. Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function	3 months
Primary	Renal function: estimated GFR (eGFR)	ill be estimated by estimated GFR (eGFR) using Modification of Diet in Renal Disease (MDRD) equation (Levey et al., 2006).; Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function	3 months
Primary	Transforming growth factor beta (TGF-ß) urine level	will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN	pre-surgery, at 24 hours and at 1 month
Primary	Monocyte chemoattractant protein (MCP-1) urine level	will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN	pre-surgery, at 24 hours and at 1 month
Secondary	Hospital stay	from time of surgery till time of patient discharge.	perioperatively
Secondary	Post operative pain	by Visual Analogue Scale The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "0 or no pain" and "100 or worst pain".	perioperatively