The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas

Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Sponsors

Lead sponsor: Gundersen Lutheran Medical Foundation

Collaborator: Gundersen Lutheran Health System

Source Gundersen Lutheran Medical Foundation
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.

Overall Status Terminated
Start Date August 2012
Completion Date December 2014
Primary Completion Date December 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patency rates 2 years postoperative
Secondary Outcome
Measure Time Frame
Surgical complications 2 years postoperative
Enrollment 38
Condition
Intervention

Intervention type: Device

Intervention name: Clipped anastomosis

Description: The vascular clip devise will be used to complete the anastomosis during fistula creation.

Arm group label: Clipped anastomosis

Other name: Anastoclip (Le Maitre)

Intervention type: Procedure

Intervention name: Handsewn anastomosis

Description: a handsewn anastomosis technique will be used during fistula creation.

Arm group label: Handsewn anastomosis

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clark A Davis, MD Principal Investigator Gundersen Lutheran Health System
Location
facility Gundersen Lutheran Health System
Location Countries

United States

Verification Date

September 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Gundersen Lutheran Medical Foundation

Investigator full name: Kara Kallies

Investigator title: Advanced Research Associate, on behalf of Clark Davis, MD (PI)

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Clipped anastomosis

Arm group type: Experimental

Description: A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.

Arm group label: Handsewn anastomosis

Arm group type: Active Comparator

Description: A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov