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

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ClinicalTrials.gov Identifier: NCT01608568
Recruitment Status : Unknown
Verified May 2012 by Jasmine Tan-Kim, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : May 31, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Jasmine Tan-Kim, University of California, San Diego

Brief Summary:

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 or disease Intervention/treatment Phase
Prolapse Device: Device is the type of suture used: Quill suture vs. Interrupted suture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL
Study Start Date : November 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Mesh attachment interval [ Time Frame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours ]
    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 :
  1. Anatomic outcomes using the two suture types [ Time Frame: 6 months post-operatively ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical