Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
Primary Purpose
Arteriovenous Fistula Complications and Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clipped anastomosis
Handsewn anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula Complications and Failure focused on measuring Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access
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.
Sites / Locations
- Gundersen Lutheran Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clipped anastomosis
Handsewn anastomosis
Arm Description
A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.
A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.
Outcomes
Primary Outcome Measures
Patency rates
Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
Secondary Outcome Measures
Surgical complications
Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.
Full Information
NCT ID
NCT01669850
First Posted
August 16, 2012
Last Updated
September 4, 2015
Sponsor
Gundersen Lutheran Medical Foundation
Collaborators
Gundersen Lutheran Health System
1. Study Identification
Unique Protocol Identification Number
NCT01669850
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
minimal accrual
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gundersen Lutheran Medical Foundation
Collaborators
Gundersen Lutheran Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula Complications and Failure
Keywords
Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clipped anastomosis
Arm Type
Experimental
Arm Description
A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.
Arm Title
Handsewn anastomosis
Arm Type
Active Comparator
Arm Description
A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.
Intervention Type
Device
Intervention Name(s)
Clipped anastomosis
Other Intervention Name(s)
Anastoclip (Le Maitre)
Intervention Description
The vascular clip devise will be used to complete the anastomosis during fistula creation.
Intervention Type
Procedure
Intervention Name(s)
Handsewn anastomosis
Intervention Description
a handsewn anastomosis technique will be used during fistula creation.
Primary Outcome Measure Information:
Title
Patency rates
Description
Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Surgical complications
Description
Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.
Time Frame
2 years postoperative
Other Pre-specified Outcome Measures:
Title
Cost
Description
Cost for the vascular clip device will be compared to cost of the handsewn technique.
Time Frame
1 year postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark A Davis, MD
Organizational Affiliation
Gundersen Lutheran Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gundersen Lutheran Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11296337
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.
Results Reference
background
PubMed Identifier
14672769
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.
Results Reference
background
PubMed Identifier
22104322
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.
Results Reference
background
PubMed Identifier
12891102
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.
Results Reference
background
PubMed Identifier
16193217
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.
Results Reference
background
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Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
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