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

NCT01413607 | Terminated Phase 4

• 1 other identifier: Dalhousieurosrs-2011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Neoplasms

Keywords

nephrectomy; self retaining sutures; laparoscopy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Warm or cold ischemia time.

  Intraoperative

• Total operative time

  Intraoperative

• Length of hospital stay measured in days

  Postoperative. Average stay following partial nephrectomy is 3 days

• Estimated blood loss during the procedure

  Intraoperative

Study Arms (2)

Quill knotless tissue-closure device

EXPERIMENTAL

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

2-0 absorbable vicryl suture

ACTIVE COMPARATOR

Participants in this group will be receiving traditional 2-0 vicryl sutures (Ethicon) during partial nephrectomy.

Device: 2-0 absorbable vicryl suture

Interventions

Quill knotless tissue-closure device 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.

Also known as: Quill Knotless Tissue-Closure Device (RA-1000Q)

Quill knotless tissue-closure device

2-0 absorbable vicryl suture DEVICE

In the control group a traditional 2-0 absorbable vicryl suture (Ethicon) will be used to close the central defect in the kidney.

Also known as: Ethicon 2-0 absorbable vicryl suture

2-0 absorbable vicryl suture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• any person who is being treated for kidney cancer with partial nephrectomy.

You may not qualify if:

• those from whom we cannot obtain adequate informed consent.
• those that are converted from partial to radical nephrectomy intraoperatively.

Sponsors & Collaborators

• Ricardo Rendon: lead

Study Sites (1)

CDHA QEII site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (6)

• Becker F, Siemer S, Kamradt J, Zwergel U, Stockle 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.

  PMID: 19568369 BACKGROUND

• Becker F, Van Poppel H, Hakenberg OW, Stief C, Gill I, Guazzoni G, Montorsi F, Russo P, Stockle 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.

  PMID: 19656615 BACKGROUND

• 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. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.

  PMID: 17574056 BACKGROUND

• Nguyen MM, Gill IS. Halving ischemia time during laparoscopic partial nephrectomy. J Urol. 2008 Feb;179(2):627-32; discussion 632. doi: 10.1016/j.juro.2007.09.086. Epub 2007 Dec 21.

  PMID: 18082215 BACKGROUND

• 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.

  PMID: 18289584 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ricardo A Rendon, MD

  Capital distrcit health authority, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: urologist

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 10, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CA (1)