Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05498246
Collaborator
(none)
60
1
2
12.6
4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic partial nephrectomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients were divided into two groups by close envelope method in this prospective study. group (A) included 30 cases in which we used bipolar coagulation for hemostasis ,group (B) included 30 cases in which we used suture renorrhaphy.Patients were divided into two groups by close envelope method in this prospective study. group (A) included 30 cases in which we used bipolar coagulation for hemostasis ,group (B) included 30 cases in which we used suture renorrhaphy.
Masking:
Single (Participant)
Masking Description:
Patients were divided into two groups by close envelope method in this prospective study. group (A) included 30 cases in which we used bipolar coagulation for hemostasis ,group (B) included 30 cases in which we used suture renorrhaphy.
Primary Purpose:
Treatment
Official Title:
Bipolar Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumour Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study
Actual Study Start Date :
Dec 5, 2020
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Dec 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group (A) included 30 cases in which we used bipolar coagulation for hemostasis

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mohamed Kadry Mostafa Banhā Qalubia Egypt 013

Sponsors and Collaborators

  • Benha University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Kadry Mostafa, Bipolar coagulation versus suture renorrhaphy for hemostasis of tumour bed in laparoscopic partial nephrectomy: prospective randomized comparative study, Benha University
ClinicalTrials.gov Identifier:
NCT05498246
Other Study ID Numbers:
  • Lap in partial nephrectomy
First Posted:
Aug 12, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2022