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To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suture renorrhaphy group | Active Comparator | involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed. |
|
| thulium beam coagulation group | Active Comparator | involves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy | Procedure | 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. |
| 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 |
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehab Atallah, A. Lecturer | Contact | 00201009661125 | Ehab44ehab@gmail.com | |
| Hesham AboZied, Professor | Contact | 00201062087567 | urologydepartment@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Aly Abdel-Karim, Professor | Alexandria University | Study Director |
| Abdel-Rahman Ebeid, Professor | Al-Azhar University-Cairo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Department, Al-Azhar University Hospitals | Recruiting | Cairo | 11511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41405625 | Derived | Atallah E, Dawoud A, Ahmed AF, Ebeid A, Soliman A, Abdelazim H, Soliman A, Abdelhamid S, Abdel-Karim AM. Randomized trial of thulium laser-assisted tumor bed coagulation versus conventional suture renorrhaphy in laparoscopic partial nephrectomy: impact on perioperative outcomes and fibrosis biomarker response. World J Urol. 2025 Dec 17;44(1):53. doi: 10.1007/s00345-025-06074-6. |
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Patient data sheet, patient consent forms through my e-mail: Ehab44ehab@gmail.com
The data will be available after 1 year may extend to another 1 year.
My e-mail: Ehab44ehab@gmail.com
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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.
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| Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy | Procedure | 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. |
|
| 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 |
| perioperatively |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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