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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benha University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings