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

Kidney Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01413607
• Other study ID #: Dalhousieurosrs-2011
• Status: Terminated
• Phase: Phase 4
• Start date: September 2011

Study information

• Verified date: July 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	CDHA QEII site	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Ricardo Rendon

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Becker F, Siemer S, Kamradt J, Zwergel U, Stöckle 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. Review. — View Citation

Becker F, Van Poppel H, Hakenberg OW, Stief C, Gill I, Guazzoni G, Montorsi F, Russo P, Stöckle 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. Review. — View Citation

El-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

Gill 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. Epub 2007 May 11. — View Citation

Nguyen MM, Gill IS. Halving ischemia time during laparoscopic partial nephrectomy. J Urol. 2008 Feb;179(2):627-32; discussion 632. Epub 2007 Dec 21. — View Citation

Turna 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data will be collected up to 12 weeks following the procedure
Primary	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).	Data will be collected up to 12 weeks following the procedure
Secondary	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.	Intraoperative
Secondary	Total operative time		Intraoperative
Secondary	Length of hospital stay measured in days		Postoperative. Average stay following partial nephrectomy is 3 days
Secondary	Estimated blood loss during the procedure		Intraoperative