Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917054
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2023-06-15
Brief Title:
Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection
Sponsor:
Istinye University
Organization:
Istinye University
Study Overview
Official Title:
Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection in Terms of Post-renal Transplant Drainage and Back-table Preparation Times
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The usage of vessel sealing devices has been gaining popularity in all surgical specialties Post-renal transplant drain placement is a common practice among transplant surgeons However prolonged drainage accompanied by surgical wound complications and perirenal fluid collections is a frequent complication experienced by the recipients This study aimed to compare bipolar sealing with conventional back-table dissection in terms of post-renal transplant drainage duration amount surgical wound complication and back-table preparation time
Detailed Description:
Consecutive recipients receiving a living donor kidney transplant at Istinye University Organ Transplantation Center will be enrolled in this study Istinye University Hospital Ethical Review Committee approved the clinical study 22021K-66 Informed consent will be obtained from all individual participants included in this study The recipients will be randomized into two groups by a simple randomization ie flipping coin method In Group 1 bipolar sealing method will be used and in Group 2 conventional silk tie ligature will be used during the back-table dissections of the harvested grafts Data parameters including recipient age gender body mass index BMI cause of end-stage renal disease dialysis modality postoperative pain surgical drainage duration back-table time cold ischemia time and surgical site infections will be collected on a database by a research nurse The exclusion criteria will be pediatric recipients and recipients who had received a kidney transplant previously The donor nephrectomies will be performed using a pure laparoscopic technique A standard rightleft lower Gibson incision will be made in every recipient and the renal bed will be prepared extraperitoneally The external iliac vein and external iliac artery will be used for graft vessel anastomosis Lymphatic vessels will be tied by 30 and 20 silk sutures in the conventional group whereas bipolar sealing method will be used in the other
Study investigators will be blinded to patient randomizations All vascular anastomoses and bladder-ureter anastomoses will be performed by the primary surgeon EE One closed-suction Hemovac drain will be placed at the lower pole of the graft in all recipients and it will be removed when discharge is less than 50 ml over 24 hours The Gregoir-Lich anti-reflux anastomosis technique performed all ureteroneocystostomies with Polydioxanone PDS sutures A double J stent will be inserted in all cases A Foley catheter will also be placed in the bladder and removed on the fourth postoperative day as recommended in the literature All patients will be evaluated for pain on the postoperative 1 st day The pain will be assessed with a visual analog scale scoring from 0 to 10 with 0 being no pain and 10 being the worst pain ever experienced Triple immunosuppression with tacrolimus mycophenolate mofetil and steroid will be initiated on post-renal transplant day 1 to all recipients In addition high-risk recipients will receive thymoglobulin as induction while low-risk recipients will receive Basiliximab on days 0 and 4 post-transplant All recipients will be anticoagulated by daily subcutaneous enoxaparin 06 cc injections starting on the day of surgery until the day of discharge Patients will be followed in terms of pain drainage length and wound complications for 6 months Surgical wounds will be assessed daily during the post-transplant 1 st week then weekly afterward
Study investigators will be blinded to patient randomizations All vascular anastomoses and bladder-ureter anastomoses will be performed by the primary surgeon EE One closed-suction Hemovac drain will be placed at the lower pole of the graft in all recipients and it will be removed when discharge is less than 50 ml over 24 hours The Gregoir-Lich anti-reflux anastomosis technique performed all ureteroneocystostomies with Polydioxanone PDS sutures A double J stent will be inserted in all cases A Foley catheter will also be placed in the bladder and removed on the fourth postoperative day as recommended in the literature All patients will be evaluated for pain on the postoperative 1 st day The pain will be assessed with a visual analog scale scoring from 0 to 10 with 0 being no pain and 10 being the worst pain ever experienced Triple immunosuppression with tacrolimus mycophenolate mofetil and steroid will be initiated on post-renal transplant day 1 to all recipients In addition high-risk recipients will receive thymoglobulin as induction while low-risk recipients will receive Basiliximab on days 0 and 4 post-transplant All recipients will be anticoagulated by daily subcutaneous enoxaparin 06 cc injections starting on the day of surgery until the day of discharge Patients will be followed in terms of pain drainage length and wound complications for 6 months Surgical wounds will be assessed daily during the post-transplant 1 st week then weekly afterward
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None