Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection

NCT05917054 | Completed

• 1 other identifier: 2/2021.K-66
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Drain Site Complication

Outcome Measures

Primary Outcomes (1)

• Drainage duration

  Time between renal transplantation and removal of the surgical drain

  days

Secondary Outcomes (1)

• Wound complications

  months

Study Arms (2)

Group 1-bipolar sealing

During the back-table preparation stage of these kidney transplant recipients, bipolar sealing method will be used for sealing the small vessels and lymphatics of the renal allograft.

Other: use of bipolar vascular sealing method on the renal allograft at the back-table stage

Group 2-conventional silk tie

During the back-table preparation stage of these kidney transplant recipients, conventional silk-tie method will be used for sealing the small vessels and lymphatics of the renal allograft.

Other: use of bipolar vascular sealing method on the renal allograft at the back-table stage

Interventions

use of bipolar vascular sealing method on the renal allograft at the back-table stage OTHER

Ligation of small vessels and lymphatics of the renal graft at the back-table stage prior to transplantation to the recipient is a routine practice in kidney transplantation. Bipolar vascular sealing method will be used for this purpose in Group 1, while the conventional silk-tie method will be used in Group 2.

Group 1-bipolar sealing; Group 2-conventional silk tie

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (aged 18 or higher) patients with end-stage renal disease scheduled for a live donor kidney transplantation and consent to participation in this study.

You may qualify if:

• Adult (aged 18 or higher) patients who will undergo a live-donor kidney transplant surgery in Istinye University Hospital and consent to participation in this study.

You may not qualify if:

• Pediatric (age lower than 18) recipients
• Patients who received kidney transplant before

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Eryigit Eren, MD

  Istinye University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 23, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)