Recruiting

Quill™ SRS

Sponsor:

UCLA

Code:

NCT01608568

Conditions

Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Prolapse

Study ID

NCT01608568

Start date

Nov, 2010

Status verified date

May, 2012

Completion date

Aug, 2013

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Interrupted suture

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)

Interventions

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).

Primary outcome measure

  • Mesh attachment interval [ Time Frame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours ]

Central Contacts and Locations

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Cara Grimes, MD

858-657-8737cgrimes@ucsd.edu

Jasmine Tan-Kim, MD

619-221-6200jstan@ucsd.edu

Principal Investigator:

Jasmine Tan-Kim, MD, MAS

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 1, 2012

Last verified

May, 2012

Keywords

  • Sutures
  • Pelvic Organ Prolapse
  • Sacrocolpopexy
  • Robotic Assisted Laparoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2012-06-01.