Clinical trial NCT01608568: Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy
Official title: AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prolapse
Keywords: Sutures
Pelvic Organ Prolapse
Sacrocolpopexy
Robotic Assisted Laparoscopy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mesh attachment interval
timeFrame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours
Secondary outcomes:
measure: Anatomic outcomes using the two suture types
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: 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.