AzTrials
AzTrials

Drain Site ComplicationNCT05917054

Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection

An observational study of Drain Site Complication, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drain Site Complication
What is being tested?
use of bipolar vascular sealing method on the renal allograft at the back-table stage
How many people
98 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 1 Jan 2023
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection in Terms of Post-renal Transplant Drainage and Back-table Preparation Times

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • use of bipolar vascular sealing method on the renal allograft at the back-table stageOther

    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.

Study groups in NCT05917054
Study groupRoleWhat they receive
Group 1-bipolar sealingDuring 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.
Receives: Other: use of bipolar vascular sealing method on the renal allograft at the back-table stage
Group 2-conventional silk tieDuring 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.
Receives: Other: use of bipolar vascular sealing method on the renal allograft at the back-table stage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drainage duration

    Time between renal transplantation and removal of the surgical drain

    Measured: days

Secondary outcomes (1)
  1. Wound complications

    Emergence of wound complications

    Measured: months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
98 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917054
Sponsor's protocol ID
2/2021.K-66
Status last verified
Jun 2023
First submitted
15 Jun 2023
Last updated
23 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Drain Site Complication, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drainage duration (time frame: days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in