The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy
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|ClinicalTrials.gov Identifier: NCT01413607|
Recruitment Status : Unknown
Verified August 2011 by Nova Scotia Health Authority.
Recruitment status was: Not yet recruiting
First Posted : August 10, 2011
Last Update Posted : August 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasms||Device: Quill knotless tissue-closure device Device: 2-0 absorbable vicryl suture||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
Experimental: Quill knotless tissue-closure device
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.
Device: Quill knotless tissue-closure device
The Quill knotless tissue-closure device is a barbed suture that allows the surgeon to keep tissue approximation without maintaining tension on the suture.
Other Name: Quill Knotless Tissue-Closure Device (RA-1000Q)
Active Comparator: 2-0 absorbable vicryl suture
Participants in this group will be receiving traditional 2-0 vicryl sutures (Ethicon) during partial nephrectomy.
Device: 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.
Other Name: Ethicon 2-0 absorbable vicryl suture
- 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).
- Warm or cold ischemia time. [ Time Frame: Intraoperative ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413607
|Contact: Ricardo A Rendon, MD||(902) email@example.com|
|Canada, Nova Scotia|
|CDHA QEII site|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Ricardo A Rendon, MD||Capital distrcit health authority, Canada|