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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 (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, 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 (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS IIâ„¢, 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 (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, 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 (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interrupted suture | Active Comparator | interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, Ethicon, Somerville, NJ, USA) |
|
| Quill suture | Active Comparator | self-anchoring 1 barbed delayed absorbable suture (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quill suture vs. Interrupted suture | Procedure | To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, Ethicon, Somerville, NJ, USA). |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh attachment interval | To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS IIâ„¢, Ethicon, Somerville, NJ, USA)in terms of time. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomic outcomes using the two suture types | To compare laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quillâ„¢ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS IIâ„¢, Ethicon, Somerville, NJ, USA). We will also assess mesh erosion rates, costs, and surgeon satisfaction rates. |
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INCLUSION CRITERIA
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente San Diego | San Diego | California | 92110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25421934 | Derived | 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. |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 6 months post-operatively |