Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial
Brief Summary: 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.


Options:
A: Arm Label: Gore-Tex permanent suture; Type: ACTIVE_COMPARATOR; Interventions: Other: Polytetrafluoroethylene | Arm Label: PDS delayed absorbable suture; Type: EXPERIMENTAL; Interventions: Other: Polydioxanone | Intervention Type: OTHER; Name: Polytetrafluoroethylene; Assigned to Arm(s): Gore-Tex permanent suture | Intervention Type: OTHER; Name: Polydioxanone; Assigned to Arm(s): PDS delayed absorbable suture
B: Arm Label: Prolift mesh; Type: ACTIVE_COMPARATOR; Interventions: Device: synthetic monofilament polypropylene mesh | Arm Label: Prolapse repair without mesh; Type: ACTIVE_COMPARATOR; Interventions: Device: synthetic monofilament polypropylene mesh | Intervention Type: DEVICE; Name: synthetic monofilament polypropylene mesh; Assigned to Arm(s): Prolapse repair without mesh, Prolift mesh
C: Arm Label: Enrollment video arm; Type: EXPERIMENTAL; Interventions: Behavioral: Enrollment video | Arm Label: No video intervention arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ULS; Type: EXPERIMENTAL; Interventions: Procedure: ULS | Arm Label: SSLF; Type: EXPERIMENTAL; Interventions: Procedure: SSLF | Arm Label: PMT; Type: EXPERIMENTAL; Interventions: Behavioral: PMT | Arm Label: Usual Care; Type: OTHER; Interventions: Other: Usual Care | Intervention Type: BEHAVIORAL; Name: Enrollment video; Assigned to Arm(s): Enrollment video arm | Intervention Type: PROCEDURE; Name: SSLF; Assigned to Arm(s): SSLF | Intervention Type: PROCEDURE; Name: ULS; Assigned to Arm(s): ULS | Intervention Type: BEHAVIORAL; Name: PMT; Assigned to Arm(s): PMT | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
D: Arm Label: Interrupted suture; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Quill suture vs. Interrupted suture | Arm Label: Quill suture; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Quill suture vs. Interrupted suture | Intervention Type: PROCEDURE; Name: Quill suture vs. Interrupted suture; Assigned to Arm(s): Interrupted suture, Quill suture

Answer: D