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Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc) (QUILL-LSC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01551992
First received: March 9, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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 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
Procedure: 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 Laparoscopic Sacrocolpopexy Randomized Controlled Trial

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Mesh attachment interval [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
    To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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 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.


Enrollment: 32
Study Start Date: November 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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)
Procedure: Quill suture vs. Interrupted suture
To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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).
Active Comparator: Quill suture
self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada)
Procedure: Quill suture vs. Interrupted suture
To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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).

  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 LSC 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
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: NCT01551992

Locations
United States, California
Kaiser Permanente San Diego
San Diego, California, United States, 92110
Sponsors and Collaborators
Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01551992     History of Changes
Other Study ID Numbers: Quill LSC
Study First Received: March 9, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Sutures
Pelvic Organ Prolapse
Sacrocolpopexy
Laparoscopy

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014