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The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy

Phase 4
Not Enrolling
Kidney Neoplasms

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Trial Information

The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy

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.

Inclusion Criteria:

- any person who is being treated for kidney cancer with partial nephrectomy.

Exclusion Criteria:

- those from whom we cannot obtain adequate informed consent.

- those that are converted from partial to radical nephrectomy intraoperatively.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Postoperative bleeding

Outcome Description:

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.

Outcome Time Frame:

Data will be collected up to 12 weeks following the procedure

Safety Issue:


Principal Investigator

Ricardo A Rendon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Capital distrcit health authority, Canada


Canada: Institutional review board

Study ID:




Start Date:

September 2011

Completion Date:

March 2013

Related Keywords:

  • Kidney Neoplasms
  • nephrectomy
  • self retaining sutures
  • laparoscopy
  • Neoplasms
  • Kidney Neoplasms