Clinical trial NCT06322745: Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy
Official title: Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Tumor
Renal Malignant Tumor
Keywords: Thulium laser
Laparoscopic partial nephrectomy
Ischemia time
Small renal mass
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).
timeFrame: during the surgery
measure: Suture time and operative time in minutes
timeFrame: during the surgery
measure: Intraoperative number of sutures for renorraphy
timeFrame: during the surgery
measure: Intraoperative Blood loss
timeFrame: during the surgery
measure: Blood transfusion rate
timeFrame: perioperatively
measure: Renal function: serum creatinine
timeFrame: 3 months
measure: Renal function: estimated GFR (eGFR)
timeFrame: 3 months
measure: Transforming growth factor beta (TGF-β) urine level
timeFrame: pre-surgery, at 24 hours and at 1 month
measure: Monocyte chemoattractant protein (MCP-1) urine level
timeFrame: pre-surgery, at 24 hours and at 1 month
Secondary outcomes:
measure: Hospital stay
timeFrame: perioperatively
measure: Post operative pain
timeFrame: perioperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology Department, Al-Azhar University Hospitals
Study officials:
affiliation: Alexandria University
name: Aly Abdel-Karim, Professor
role: STUDY_DIRECTOR
affiliation: Al-Azhar University-Cairo
name: Abdel-Rahman Ebeid, Professor
role: STUDY_DIRECTOR
References: