Renal TumorNCT06322745
Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy
A study testing Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy and Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy in people with Renal Tumor and Renal Malignant Tumor, run by Al-Azhar University at 1 site in Egypt.
Trial summary
To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Renal Tumor, Renal Malignant Tumor
- What is being tested?
- Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy and Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cT1 single renal mass.
Who cannot join
- Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary insufficiency, and chronic obstructive lung disease).
- Renal mass involving the hilum.
- Renal mass in patients with chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology Department, Al-Azhar University Hospitals
Cairo, 11511
Malakah Mohammed, Secretary, +20225107222, urologydepartment@azhar.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Tumor, Renal Malignant Tumor
- Being tested
- Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy, Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy
- Keywords
- Thulium laser, Laparoscopic partial nephrectomy, Ischemia time, Small renal mass
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomyProcedure or surgery
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 nephrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| suture renorrhaphy group | Active comparator | involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed. Receives: Procedure: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy |
| 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 Receives: Procedure: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: during the surgery
Intraoperative number of sutures for renorraphy
which is the count of each time the needle comes out from the renal parenchyma.
Measured: during the surgery
Intraoperative Blood loss
Blood loss will be calculated from the suction jar minus the amount of fluid irrigation
Measured: during the surgery
Blood transfusion rate
Amount of blood in ml transfused intraoperative or postoperative
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-surgery, at 24 hours and at 1 month
Secondary outcomes (2)
Hospital stay
from time of surgery till time of patient discharge.
Measured: 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".
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jun 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TumorStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohammed Ali Atallah, Al-Azhar University
- Investigators
- Aly Abdel-Karim, Professor, Study director, Alexandria UniversityAbdel-Rahman Ebeid, Professor, Study director, Al-Azhar University-Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322745
- Sponsor's protocol ID
- 1986
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient data sheet, patient consent forms through my e-mail: Ehab44ehab@gmail.com
Publications
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.
PubMed 41405625
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06322745
- Acronym / sponsor ID
- 1986
- Conditions
- Renal Tumor, Renal Malignant Tumor
- Keywords
- Thulium laser, Laparoscopic partial nephrectomy, Ischemia time, Small renal mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| suture renorrhaphy group | Active comparator | Procedure: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomyinvolves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed. |
| thulium beam coagulation group | Active comparator | Procedure: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomyinvolves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cT1 single renal mass.
Key exclusion criteria (3 listed)
- Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary insufficiency, and chronic obstructive lung disease).
- Renal mass involving the hilum.
- Renal mass in patients with chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomySuture 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. | Procedure or surgery | suture renorrhaphy group |
| Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomyA 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. | Procedure or surgery | thulium beam coagulation group |
Primary outcome
Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).
Time frame: 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
Suture time and operative time in minutes
Time frame: during the surgery
Suture time starts from the first suture to the last one, including time of manipulating needles.
Intraoperative number of sutures for renorraphy
Time frame: during the surgery
which is the count of each time the needle comes out from the renal parenchyma.
Intraoperative Blood loss
Time frame: during the surgery
Blood loss will be calculated from the suction jar minus the amount of fluid irrigation
Blood transfusion rate
Time frame: perioperatively
Amount of blood in ml transfused intraoperative or postoperative
Renal function: serum creatinine
Time frame: 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)
Time frame: 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
Time frame: 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
Monocyte chemoattractant protein (MCP-1) urine level
Time frame: 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
2 secondary outcomes
Hospital stay
Time frame: perioperatively
Post operative pain
Time frame: perioperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 41405625Atallah 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.
- Individual participant dataSharing planned: Yes. Patient data sheet, patient consent forms through my e-mail: Ehab44ehab@gmail.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aly Abdel-Karim, Professor study director
Alexandria University
Abdel-Rahman Ebeid, Professor study director
Al-Azhar University-Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy and Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy in people with Renal Tumor and Renal Malignant Tumor, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehab Atallah, A. Lecturer (00201009661125, Ehab44ehab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping). (time frame: during the surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.