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

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

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

Study Overview

• Status: Recruiting
• Conditions: Renal Tumor; Renal Malignant Tumor
• Intervention / Treatment: Procedure: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy; Procedure: Thulium beam coagulation and 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ehab Atallah, A. Lecturer; Phone Number: 00201009661125; Email: Ehab44ehab@gmail.com
• Study Contact Backup: Name: Hesham AboZied, Professor; Phone Number: 00201062087567; Email: urologydepartment@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Urology Department, Al-Azhar University Hospitals
    • Contact: Malakah Mohammed, Secretary; Phone Number: +20225107222; Email: urologydepartment@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: suture renorrhaphy group; involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.	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.
Active Comparator: thulium beam coagulation group; involves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Intraoperative number of sutures for renorraphy	which is the count of each time the needle comes out from the renal parenchyma.	during the surgery
Intraoperative Blood loss	Blood loss will be calculated from the suction jar minus the amount of fluid irrigation	during the surgery
Blood transfusion rate	Amount of blood in ml transfused intraoperative or postoperative	perioperatively
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
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
Transforming growth factor beta (TGF-β) 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	from time of surgery till time of patient discharge.	perioperatively
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Aly Abdel-Karim, Professor, Alexandria University; Study Director: Abdel-Rahman Ebeid, Professor, Al-Azhar University-Cairo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic partial nephrectomy; Thulium laser; Small renal mass; Ischemia time
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Carcinoma, Renal Cell; Coagulants; Hemostatics
• Other Study ID Numbers: 1986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient data sheet, patient consent forms through my e-mail: Ehab44ehab@gmail.com
• IPD Sharing Time Frame: The data will be available after 1 year may extend to another 1 year.
• IPD Sharing Access Criteria: My e-mail: Ehab44ehab@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No