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

NCT06322745 | Recruiting DMC

• 1 other identifier: 1986
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Tumor; Renal Malignant Tumor

Keywords

Thulium laser; Laparoscopic partial nephrectomy; Ischemia time; Small renal mass

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Hospital stay

  perioperatively

• Post operative pain

  perioperatively

Study Arms (2)

suture renorrhaphy group

ACTIVE COMPARATOR

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

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

Procedure: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy

Interventions

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.

suture renorrhaphy group

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.

thulium beam coagulation group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• cT1 single renal mass.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospitals

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Aly Abdel-Karim, Professor

  Alexandria University

  STUDY DIRECTOR

• Abdel-Rahman Ebeid, Professor

  Al-Azhar University-Cairo

  STUDY DIRECTOR

Central Study Contacts

Ehab Atallah, A. Lecturer

CONTACT

00201009661125; Ehab44ehab@gmail.com

Hesham AboZied, Professor

CONTACT

00201062087567; urologydepartment@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 21, 2024
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after 1 year may extend to another 1 year.
• Access Criteria: My e-mail: Ehab44ehab@gmail.com

Locations

EG (1)