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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01413607
First received: August 2, 2011
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Kidney Neoplasms
Device: Quill knotless tissue-closure device
Device: 2-0 absorbable vicryl suture
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of Self Retaining Sutures in Open and Laparoscopic Partial Nephrectomy

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Postoperative bleeding [ Time Frame: Data will be collected up to 12 weeks following the procedure ] [ Designated as safety issue: No ]
    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.

  • Urinary leakage [ Time Frame: Data will be collected up to 12 weeks following the procedure ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Warm or cold ischemia time. [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    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.

  • Total operative time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Length of hospital stay measured in days [ Time Frame: Postoperative. Average stay following partial nephrectomy is 3 days ] [ Designated as safety issue: No ]
  • Estimated blood loss during the procedure [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quill knotless tissue-closure device
During partial nephrectomy participants in this group will receive the Quill Knotless Tissue-Closure device (Angiotech Pharmaceuticals) to close the central defect in their kidney.
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.
Other Name: Quill Knotless Tissue-Closure Device (RA-1000Q)
Active Comparator: 2-0 absorbable vicryl suture
Participants in this group will be receiving traditional 2-0 vicryl sutures (Ethicon) during partial nephrectomy.
Device: 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.
Other Name: Ethicon 2-0 absorbable vicryl suture

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413607

Contacts
Contact: Ricardo A Rendon, MD (902) 425-3940 rrendon@dal.ca

Locations
Canada, Nova Scotia
CDHA QEII site Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Ricardo A Rendon, MD Capital distrcit health authority, Canada
  More Information

Publications:
Responsible Party: Dr. Ricardo Rendon, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01413607     History of Changes
Other Study ID Numbers: Dalhousieurosrs-2011
Study First Received: August 2, 2011
Last Updated: August 9, 2011
Health Authority: Canada: Institutional Review Board

Keywords provided by Capital District Health Authority, Canada:
nephrectomy
self retaining sutures
laparoscopy

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014