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

Not Applicable

Recruiting

• Conditions: Renal Malignant Tumor; Renal Tumor
• Interventions: 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

• Registration Number: NCT06322745
• Lead Sponsor: Al-Azhar University

Brief 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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suture renorrhaphy group	Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy	involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.
thulium beam coagulation group	Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy	involves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed

Primary Outcome Measures

Name	Time	Method
Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).	during the surgery	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
Intraoperative number of sutures for renorraphy	during the surgery	which is the count of each time the needle comes out from the renal parenchyma.
Intraoperative Blood loss	during the surgery	Blood loss will be calculated from the suction jar minus the amount of fluid irrigation
Blood transfusion rate	perioperatively	Amount of blood in ml transfused intraoperative or postoperative
Renal function: serum creatinine	3 months	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
Renal function: estimated GFR (eGFR)	3 months	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
Transforming growth factor beta (TGF-β) urine level	pre-surgery, at 24 hours and at 1 month	will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN
Suture time and operative time in minutes	during the surgery	Suture time starts from the first suture to the last one, including time of manipulating needles.
Monocyte chemoattractant protein (MCP-1) urine level	pre-surgery, at 24 hours and at 1 month	will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN

Secondary Outcome Measures

Name	Time	Method
Hospital stay	perioperatively	from time of surgery till time of patient discharge.
Post operative pain	perioperatively	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".

Trial Locations

Locations (1)

Urology Department, Al-Azhar University Hospitals; 🇪🇬 Cairo, Egypt