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CompletedNCT05917054Updated Jun 23, 2023

Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection

An observational study in Drain Site Complication, sponsored by Istinye University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Istinye University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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 (2/2021.K-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 (i.e., 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 right/left 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 3/0 and 2/0 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 (E.E). 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 0,6 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.

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Conditions studied

  • Drain Site Complication
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In context

Lead sponsor

Istinye University is the lead sponsor of 216 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • Pediatric (age lower than 18) recipients
  • Patients who received kidney transplant before
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
98 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Otheruse of bipolar vascular sealing method on the renal allograft at the back-table stage

    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.

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What researchers measure

Primary outcomes

  1. Drainage duration

    Time between renal transplantation and removal of the surgical drain

    Time frame: days

Secondary outcomes

  1. Wound complications

    Emergence of wound complications

    Time frame: months

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Study locations

1 site
  • Istinye University Training and Research Hospital
    Istanbul, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05917054
Lead sponsor
Istinye University
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
Jan 1, 2021
Primary completion
Dec 31, 2022
Completion
Jan 1, 2023
Last update
Jun 23, 2023

Study contacts

Eryigit Eren, MD
principal investigator · Istinye University Training and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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