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).
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
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.
- Conditions
- Drain Site Complication
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
Drainage duration
Time between renal transplantation and removal of the surgical drain
Measured: days
Secondary outcomes (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.
- First posted23 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drain Site ComplicationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eryigit Eren, MD, Principal investigator, Istinye University Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bipolar Vascular Sealing and Conventional Back-table Dissection in Terms of Post-renal Transplant Drainage and Back-table Preparation Times
- ClinicalTrials.gov ID
- NCT05917054
- Acronym / sponsor ID
- 2/2021.K-66
- Conditions
- Drain Site Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-bipolar sealing | – | Other: use of bipolar vascular sealing method on the renal allograft at the back-table stageDuring 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. |
| Group 2-conventional silk tie | – | Other: use of bipolar vascular sealing method on the renal allograft at the back-table stageDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Pediatric (age lower than 18) recipients
- Patients who received kidney transplant before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of bipolar vascular sealing method on the renal allograft at the back-table stageLigation 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. | Other | Group 1-bipolar sealing, Group 2-conventional silk tie |
Primary outcome
Drainage duration
Time frame: days
Time between renal transplantation and removal of the surgical drain
1 secondary outcome
Wound complications
Time frame: months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eryigit Eren, MD principal investigator
Istinye University Training and Research Hospital
1 site in 1 country: see every site and its status.
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.