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Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy (Quill RALSC)

This study is currently recruiting participants.
Verified May 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Jasmine Tan-Kim, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01608568
First received: February 29, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.

2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.

2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.


Condition Intervention
Prolapse
 Device: Device is the type of suture used: Quill suture vs. Interrupted suture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Mesh attachment interval [ Time Frame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours ] [ Designated as safety issue: No ]
    To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA)in terms of time.


Secondary Outcome Measures:
  • Anatomic outcomes using the two suture types [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: Yes ]
    To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). We will also assess mesh erosion rates, costs, and surgeon satisfaction rates.


Estimated Enrollment: 32
Study Start Date: November 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interrupted suture
interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA)
 Device: Device is the type of suture used: Quill suture vs. Interrupted suture
To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
Other Name: (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) (PDS II™, Ethicon, Somerville, NJ, USA)
Active Comparator: Quill suture
self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada)
 Device: Device is the type of suture used: Quill suture vs. Interrupted suture
To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
Other Name: (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) (PDS II™, Ethicon, Somerville, NJ, USA)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  • >18 years old
  • Undergoing RALSC with or without other procedures for pelvic organ prolapse or incontinence
  • Willing to return for follow-up visits
  • Written informed consent obtained from each subject
  • Must be having a robotic assisted laparoscopic sacrocolpopexy

Exclusion Criteria:

  • Decline to participate
  • Pregnant or contemplating future pregnancy
  • Unable to participate in the informed consent process
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608568

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Cara Grimes, MD     858-657-8737     cgrimes@ucsd.edu    
Contact: Jasmine Tan-Kim, MD     619-221-6200     jstan@ucsd.edu    
Sub-Investigator: Charles W Nager, MD            
Sub-Investigator: Emily S Lukacz, MD, MAS            
Principal Investigator: Jasmine Tan-Kim, MD, MAS            
Principal Investigator: Cara L Grimes, MD            
Sub-Investigator: Heidi W Brown, MD            
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Jasmine Tan-Kim, Urogynecologist, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01608568     History of Changes
Other Study ID Numbers: Robotic Sacrocolpopexy Quill
Study First Received: February 29, 2012
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Sutures
Pelvic Organ Prolapse
Sacrocolpopexy
Robotic Assisted Laparoscopy

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013