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

NCT01608568 | Unknown

• 1 other identifier: Robotic Sacrocolpopexy Quill
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Sutures; Pelvic Organ Prolapse; Sacrocolpopexy; Robotic Assisted Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Mesh attachment interval

  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.

  Intraoperative placement of mesh - approximately 30 minutes to 2 hours

Secondary Outcomes (1)

• Anatomic outcomes using the two suture types

  6 months post-operatively

Study Arms (2)

Interrupted suture

ACTIVE COMPARATOR

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

Quill suture

ACTIVE COMPARATOR

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

Interventions

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

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).

Also known as: (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) (PDS II™, Ethicon, Somerville, NJ, USA)

Interrupted suture; Quill suture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• Decline to participate
• Pregnant or contemplating future pregnancy
• Unable to participate in the informed consent process

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Related Publications (1)

• Tan-Kim J, Nager CW, Grimes CL, Luber KM, Lukacz ES, Brown HW, Ferrante KL, Dyer KY, Kirby AC, Menefee SA. A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Int Urogynecol J. 2015 May;26(5):649-56. doi: 10.1007/s00192-014-2566-8. Epub 2014 Nov 25.

  PMID: 25421934 DERIVED

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecologist

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: May 31, 2012
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)