Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

August 10, 2022 updated by: Mohamed Kadry Mostafa, Benha University

Bipolar Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumour Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study

To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Partial nephrectomy is the standard of care for T1 renal masses (local tumour) it preserves as much normal renal tissue as possible to avoid post-operative acute renal failure, chronic kidney disease and associated metabolic and cardiovascular morbidities . The main challenges that affect partial nephrectomy outcome is the need for renal ischemia to achieve good hemostasis, and the long-term oncological consequences associated with positive surgical margin. Laparoscopic partial nephrectomy has been widely used lately as it is associated with less blood loss, short hospital stay and early recovery in comparison to open partial nephrectomy . Hemostasis of the tumor bed after laparoscopic partial nephrectomy can be achieved by various techniques including Suture renorrhaphy which can be used whatever the bleeding area, the size of bleeding vessel, or the amount of bleeding. However, it consumes more ischemia time, involves functional parenchyma, and requires high laparoscopic skills . There for in our study we tried to find a way to improve the functional and oncological outcome of laparoscopic partial nephrectomy by comparing the bipolar coagulation versus conventional suture renorrhaphy in performing stable hemostasis of tumor bed

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 013
        • Mohamed Kadry Mostafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Radiological diagnosis of renal mass less than 7cm
  • Renal mass in patients with chronic kidney disease

Exclusion Criteria:

  • Patients with Central or hilar renal masses
  • Renal masses close to pelvi-calyceal system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group (A) included 30 cases in which we used bipolar coagulation for hemostasis
Procedure: laparoscopic partial nephrectomy
Operations were done under general anesthesia. Patients were positioned in modified lateral kidney position for trans-peritoneal procedures. Pneumoperitoneum using the Veress needle technique and trocar placement . Dissection to the renal hilum for good and sufficient exposure of the renal vessels. Good exposure of the tumor and marking the excision site with electro cautery. Clamping of renal vessels using laparoscopic Bulldog appliers. Excision of the renal mass using visual assessment to determine the suitable depth of normal parenchyma to be excised in order to achieve a negative surgical margin. Unclamping was done and re-assessment of the hemostasis to secure residual bleeding points. Approximation of the edges of renal parenchyma using suturing in both groups. The specimen was placed in an EndoCatch bag and removed through pfannenstiel incisionsurgical drain was placed in the paracolic gutter
ACTIVE_COMPARATOR: group (B) included 30 cases in which we used suture renorrhaphy
Procedure: laparoscopic partial nephrectomy
Operations were done under general anesthesia. Patients were positioned in modified lateral kidney position for trans-peritoneal procedures. Pneumoperitoneum using the Veress needle technique and trocar placement . Dissection to the renal hilum for good and sufficient exposure of the renal vessels. Good exposure of the tumor and marking the excision site with electro cautery. Clamping of renal vessels using laparoscopic Bulldog appliers. Excision of the renal mass using visual assessment to determine the suitable depth of normal parenchyma to be excised in order to achieve a negative surgical margin. Unclamping was done and re-assessment of the hemostasis to secure residual bleeding points. Approximation of the edges of renal parenchyma using suturing in both groups. The specimen was placed in an EndoCatch bag and removed through pfannenstiel incisionsurgical drain was placed in the paracolic gutter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy
Time Frame: baseline frame
patients were assessed preoperative by weight in kg and height in meters weight and height will be combined to report body mass index in kg/m^2 ,base line creatinine in mil gm ,baseline hemoglobin in gm,leterality ,CT to examine size in cm and RENAL score and asses patients intra operative by operative time in minutes ,ischemic time in minutes ,estimated blood loss in gm and hospital stay in days
baseline frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: mostafa khalil, MD, Data analysis
  • Principal Investigator: Ali Abdelkarim, MD, data collections

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 5, 2020

Primary Completion (ACTUAL)

December 10, 2021

Study Completion (ACTUAL)

December 25, 2021

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (ACTUAL)

August 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Lap in partial nephrectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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