Clinical trial NCT01669850: Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
Official title: The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Fistula Complications and Failure
Keywords: Chronic kidney disease
Arteriovenous fistula
Surgical anastomosis
Complications
Patency
Dialysis access
Lead sponsor: Gundersen Lutheran Medical Foundation
Sponsor class: OTHER
Collaborators: name: Gundersen Lutheran Health System
First posted: 2012-08-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.

Detailed description: End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
* The planned AVF site must be naïve of prior AVF creations.
* Vein mapping studies completed
* 2.5 - 3mm minimum vein diameter on mapping

Exclusion Criteria:

* Less than 18 years of age.
* Inability to provide consent.
* Previous failed AVFs in both arms.
* Contraindications to AVF creation:

  * ipsilateral proximal venous and arterial occlusion or stenosis
  * systemic or local infection
  * too ill to operate
* Anticipated inability to keep 30-day postoperative follow-up appointment.

Primary outcomes:
measure: Patency rates
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Surgical complications
timeFrame: 2 years postoperative
Other outcomes:
measure: Cost
timeFrame: 1 year postoperative
Locations:
city: La Crosse
country: United States
facility: Gundersen Lutheran Health System
state: Wisconsin
Study officials:
affiliation: Gundersen Lutheran Health System
name: Clark A Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.
citation: Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.
citation: Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.
citation: Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.
citation: Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.