Kidney NeoplasmsPhase 4NCT01413607
The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy
A Phase 4 study testing Quill knotless tissue-closure device and 2-0 absorbable vicryl suture in people with Kidney Neoplasms, run by Ricardo Rendon at 1 site in Canada.
Trial summary
The objective of this study is to assess whether using a different type of suture (barbed sutures) during partial nephrectomy results in fewer postoperative complications than with traditional sutures (non-barbed). The most common complications are urine leakage and bleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Quill knotless tissue-closure device and 2-0 absorbable vicryl suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Feb 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any person who is being treated for kidney cancer with partial nephrectomy.
Who cannot join
- those from whom we cannot obtain adequate informed consent.
- those that are converted from partial to radical nephrectomy intraoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess whether using a different type of suture (barbed sutures) during partial nephrectomy results in fewer postoperative complications than with traditional sutures (non-barbed). The most common complications are urine leakage and bleeding. The investigators believe the barbed suture is less technically difficult to use and will allow the surgeon to better repair the hole left in the kidney after the tumor is removed.
Read the detailed description
With the increased use of radiographic imaging for abdominal complaints the incidental finding of small asymptomatic renal masses has increased. Partial nephrectomy has become the gold standard therapy for treatment of kidney masses ≤7cm in size. Absolute indications for partial nephrectomy include bilateral renal tumors, systemic condition affecting renal function, chronic renal insufficiency and solitary kidney function. Elective indications include masses ≤7cm and normal contralateral kidney function. The procedure can be completed through either laparoscopic or open technique. Complication rates from open and partial nephrectomy have been reported to be about 16% with the most common being urinary leak, postoperative bleeding, renal insufficiency and the need for dialysis.
A major predictor of postoperative complications is the warm ischemia time. This is the length of time the kidney is without blood flow at body temperature. It has been reported that renal and cellular damage of the nephron begins after 20-30 minutes of ischemia. As well, the volume of estimated blood loss has been shown to be a major predictor of postoperative complications. A threshold value of estimated blood loss >750 mL and warm ischemia time >45 minutes have been associated with significantly increased rates of postoperative complications. Recent advancements in laparoscopic technique have lead to the development of the early unclamping method of partial nephrectomy. In this method the renal pedicle is unclamped following the initial central running suture but before the defect has been entirely repaired with bolstering sutures. This method has been reported to decrease warm ischemia time by ≥50% in comparison to the traditional technique of unclamping after full closure of the defect.
The investigators have demonstrated the safety of the "Quill" (Angiotech, Vancouver, BC) polydioxanone barbed self retaining sutures in a retrospective series. These sutures contain unidirectionally oriented barbs on the surface that switch direction at the half-way point. Laparoscopic partial nephrectomy is a technically demanding procedure and maintaining tension during intracorporeal suturing is particularly challenging. The barbs of the self retaining sutures lock into the tissue allowing the surgeon to preserve tissue approximation without needing to maintain tension. The investigators believe these sutures will allow the surgeon to obtain greater tissue approximation therefore decreasing postoperative urinary leakage and bleeding. These findings need to be validated postoperatively.
The investigators believe that coupling the shorter warm ischemia time of the early unclamping method and the greater tissue approximation afforded by the self retaining sutures will result in fewer complications following partial nephrectomy.
- Conditions
- Kidney Neoplasms
- Being tested
- Quill knotless tissue-closure device, 2-0 absorbable vicryl suture
- Keywords
- nephrectomy, self retaining sutures, laparoscopy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quill knotless tissue-closure deviceDevice
Also called Quill Knotless Tissue-Closure Device (RA-1000Q)
The Quill knotless tissue-closure device is a barbed suture that allows the surgeon to keep tissue approximation without maintaining tension on the suture.
2-0 absorbable vicryl sutureDevice
Also called Ethicon 2-0 absorbable vicryl suture
In the control group a traditional 2-0 absorbable vicryl suture (Ethicon) will be used to close the central defect in the kidney.
| Study group | Role | What they receive |
|---|---|---|
| Quill knotless tissue-closure device | Experimental | During partial nephrectomy participants in this group will receive the Quill Knotless Tissue-Closure device (Angiotech Pharmaceuticals) to close the central defect in their kidney. Receives: Device: Quill knotless tissue-closure device |
| 2-0 absorbable vicryl suture | Active comparator | Participants in this group will be receiving traditional 2-0 vicryl sutures (Ethicon) during partial nephrectomy. Receives: Device: 2-0 absorbable vicryl suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding
Patients will be considered positive for bleeding if they have any of gross hematuria, need for transfusion in the postoperative period not believed to be from intraoperative bleeding or need for angioembolization.
Measured: Data will be collected up to 12 weeks following the procedure
Urinary leakage
Urinary leakage is defined as any leakage requiring instrumentation (stent insertion, retrograde pyelogram or percutaneous drainage) or prolonged stay of drain due to high output (>4 days).
Measured: Data will be collected up to 12 weeks following the procedure
Secondary outcomes (4)
Warm or cold ischemia time.
Warm is ischemia time is the time that the kidney is without blood perfusion while at body temperature. Cold ischemia time is the time the kidney is without blood perfusion while being cooled below body temperature.
Measured: Intraoperative
Total operative time
Measured: Intraoperative
Length of hospital stay measured in days
Measured: Postoperative. Average stay following partial nephrectomy is 3 days
Estimated blood loss during the procedure
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
Why it stopped: There was an error made in recruitment therefore patients were not randomized correctly. This was identified in February 2012 and the study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo Rendon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo Rendon, Nova Scotia Health Authority
- Investigators
- Ricardo A Rendon, MD, Principal investigator, Capital distrcit health authority, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413607
- Sponsor's protocol ID
- Dalhousieurosrs-2011
- Status last verified
- Jul 2021
- First submitted
- 2 Aug 2011
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Becker F, Siemer S, Kamradt J, Zwergel U, Stockle M. Important aspects of organ-preserving surgery for renal tumors: indications, new standards, and oncological outcomes. Dtsch Arztebl Int. 2009 Feb;106(8):117-22. doi: 10.3238/arztebl.2009.0117. Epub 2009 Feb 20.
PubMed 19568369Becker F, Van Poppel H, Hakenberg OW, Stief C, Gill I, Guazzoni G, Montorsi F, Russo P, Stockle M. Assessing the impact of ischaemia time during partial nephrectomy. Eur Urol. 2009 Oct;56(4):625-34. doi: 10.1016/j.eururo.2009.07.016. Epub 2009 Jul 28.
PubMed 19656615Gill IS, Kavoussi LR, Lane BR, Blute ML, Babineau D, Colombo JR Jr, Frank I, Permpongkosol S, Weight CJ, Kaouk JH, Kattan MW, Novick AC. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol. 2007 Jul;178(1):41-6. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.
PubMed 17574056Nguyen MM, Gill IS. Halving ischemia time during laparoscopic partial nephrectomy. J Urol. 2008 Feb;179(2):627-32; discussion 632. doi: 10.1016/j.juro.2007.09.086. Epub 2007 Dec 21.
PubMed 18082215Turna B, Frota R, Kamoi K, Lin YC, Aron M, Desai MM, Kaouk JH, Gill IS. Risk factor analysis of postoperative complications in laparoscopic partial nephrectomy. J Urol. 2008 Apr;179(4):1289-94; discussion 1294-5. doi: 10.1016/j.juro.2007.11.070. Epub 2008 Mar 4.
PubMed 18289584El-Ghazaly, T.H. and Rendon, R.A. 2011. Perioperative outcomes of laparoscopic partial nephrectomy using self-retaining sutures (SRS) and early clamp removal versus conventional kidney and collecting system repair. Canadian Urological Association Journal 5(3 suppl 1) s3-s114 sub-article 66
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01413607
- Acronym / sponsor ID
- Dalhousieurosrs-2011
- Conditions
- Kidney Neoplasms
- Keywords
- nephrectomy, self retaining sutures, laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was an error made in recruitment therefore patients were not randomized correctly. This was identified in February 2012 and the study was cancelled.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ricardo RendonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- First posted
- 10 Aug 2011 (estimated)
- 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 objective of this study is to assess whether using a different type of suture (barbed sutures) during partial nephrectomy results in fewer postoperative complications than with traditional sutures (non-barbed). The most common complications are urine leakage and bleeding. The investigators believe the barbed suture is less technically difficult to use and will allow the surgeon to better repair the hole left in the kidney after the tumor is removed.
Detailed description
With the increased use of radiographic imaging for abdominal complaints the incidental finding of small asymptomatic renal masses has increased. Partial nephrectomy has become the gold standard therapy for treatment of kidney masses ≤7cm in size. Absolute indications for partial nephrectomy include bilateral renal tumors, systemic condition affecting renal function, chronic renal insufficiency and solitary kidney function. Elective indications include masses ≤7cm and normal contralateral kidney function. The procedure can be completed through either laparoscopic or open technique. Complication rates from open and partial nephrectomy have been reported to be about 16% with the most common being urinary leak, postoperative bleeding, renal insufficiency and the need for dialysis.
A major predictor of postoperative complications is the warm ischemia time. This is the length of time the kidney is without blood flow at body temperature. It has been reported that renal and cellular damage of the nephron begins after 20-30 minutes of ischemia. As well, the volume of estimated blood loss has been shown to be a major predictor of postoperative complications. A threshold value of estimated blood loss >750 mL and warm ischemia time >45 minutes have been associated with significantly increased rates of postoperative complications. Recent advancements in laparoscopic technique have lead to the development of the early unclamping method of partial nephrectomy. In this method the renal pedicle is unclamped following the initial central running suture but before the defect has been entirely repaired with bolstering sutures. This method has been reported to decrease warm ischemia time by ≥50% in comparison to the traditional technique of unclamping after full closure of the defect.
The investigators have demonstrated the safety of the "Quill" (Angiotech, Vancouver, BC) polydioxanone barbed self retaining sutures in a retrospective series. These sutures contain unidirectionally oriented barbs on the surface that switch direction at the half-way point. Laparoscopic partial nephrectomy is a technically demanding procedure and maintaining tension during intracorporeal suturing is particularly challenging. The barbs of the self retaining sutures lock into the tissue allowing the surgeon to preserve tissue approximation without needing to maintain tension. The investigators believe these sutures will allow the surgeon to obtain greater tissue approximation therefore decreasing postoperative urinary leakage and bleeding. These findings need to be validated postoperatively.
The investigators believe that coupling the shorter warm ischemia time of the early unclamping method and the greater tissue approximation afforded by the self retaining sutures will result in fewer complications following partial nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quill knotless tissue-closure device | Experimental | Device: Quill knotless tissue-closure deviceDuring partial nephrectomy participants in this group will receive the Quill Knotless Tissue-Closure device (Angiotech Pharmaceuticals) to close the central defect in their kidney. |
| 2-0 absorbable vicryl suture | Active comparator | Device: 2-0 absorbable vicryl sutureParticipants in this group will be receiving traditional 2-0 vicryl sutures (Ethicon) during partial nephrectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any person who is being treated for kidney cancer with partial nephrectomy.
Key exclusion criteria (2 listed)
- those from whom we cannot obtain adequate informed consent.
- those that are converted from partial to radical nephrectomy intraoperatively.
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 |
|---|---|---|
| Quill knotless tissue-closure deviceAlso: Quill Knotless Tissue-Closure Device (RA-1000Q)The Quill knotless tissue-closure device is a barbed suture that allows the surgeon to keep tissue approximation without maintaining tension on the suture. | Device | Quill knotless tissue-closure device |
| 2-0 absorbable vicryl sutureAlso: Ethicon 2-0 absorbable vicryl sutureIn the control group a traditional 2-0 absorbable vicryl suture (Ethicon) will be used to close the central defect in the kidney. | Device | 2-0 absorbable vicryl suture |
Primary outcome
Postoperative bleeding
Time frame: Data will be collected up to 12 weeks following the procedure
Patients will be considered positive for bleeding if they have any of gross hematuria, need for transfusion in the postoperative period not believed to be from intraoperative bleeding or need for angioembolization.
Urinary leakage
Time frame: Data will be collected up to 12 weeks following the procedure
Urinary leakage is defined as any leakage requiring instrumentation (stent insertion, retrograde pyelogram or percutaneous drainage) or prolonged stay of drain due to high output (>4 days).
4 secondary outcomes
Warm or cold ischemia time.
Time frame: Intraoperative
Total operative time
Time frame: Intraoperative
Length of hospital stay measured in days
Time frame: Postoperative. Average stay following partial nephrectomy is 3 days
Estimated blood loss during the procedure
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: There was an error made in recruitment therefore patients were not randomized correctly. This was identified in February 2012 and the study was cancelled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Background: PubMed 19568369Becker F, Siemer S, Kamradt J, Zwergel U, Stockle M. Important aspects of organ-preserving surgery for renal tumors: indications, new standards, and oncological outcomes. Dtsch Arztebl Int. 2009 Feb;106(8):117-22. doi: 10.3238/arztebl.2009.0117. Epub 2009 Feb 20.
- Background: PubMed 19656615Becker F, Van Poppel H, Hakenberg OW, Stief C, Gill I, Guazzoni G, Montorsi F, Russo P, Stockle M. Assessing the impact of ischaemia time during partial nephrectomy. Eur Urol. 2009 Oct;56(4):625-34. doi: 10.1016/j.eururo.2009.07.016. Epub 2009 Jul 28.
- Background: PubMed 17574056Gill IS, Kavoussi LR, Lane BR, Blute ML, Babineau D, Colombo JR Jr, Frank I, Permpongkosol S, Weight CJ, Kaouk JH, Kattan MW, Novick AC. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol. 2007 Jul;178(1):41-6. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.
- Background: PubMed 18082215Nguyen MM, Gill IS. Halving ischemia time during laparoscopic partial nephrectomy. J Urol. 2008 Feb;179(2):627-32; discussion 632. doi: 10.1016/j.juro.2007.09.086. Epub 2007 Dec 21.
- Background: PubMed 18289584Turna B, Frota R, Kamoi K, Lin YC, Aron M, Desai MM, Kaouk JH, Gill IS. Risk factor analysis of postoperative complications in laparoscopic partial nephrectomy. J Urol. 2008 Apr;179(4):1289-94; discussion 1294-5. doi: 10.1016/j.juro.2007.11.070. Epub 2008 Mar 4.
- BackgroundEl-Ghazaly, T.H. and Rendon, R.A. 2011. Perioperative outcomes of laparoscopic partial nephrectomy using self-retaining sutures (SRS) and early clamp removal versus conventional kidney and collecting system repair. Canadian Urological Association Journal 5(3 suppl 1) s3-s114 sub-article 66
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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.
Ricardo A Rendon, MD principal investigator
Capital distrcit health authority, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quill knotless tissue-closure device and 2-0 absorbable vicryl suture in people with Kidney Neoplasms, run by Ricardo Rendon at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 2 Aug 2021. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: There was an error made in recruitment therefore patients were not randomized correctly. This was identified in February 2012 and the study was cancelled.). Results are not available in the source record.
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?
Postoperative bleeding (time frame: Data will be collected up to 12 weeks following the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413607, which also lists 6 linked publications.
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 2 Aug 2021.