Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL
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.


Options:
A: Arm Label: Laparoscopic Abdominal Sacrocolpopexy (LASC); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard laparoscopic abdominal sacrocolpopexy | Arm Label: Robotic Assisted Laparoscopic (RASC); Type: EXPERIMENTAL; Interventions: Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy | Intervention Type: PROCEDURE; Name: Robotic assisted laparoscopic abdominal sacrocolpopexy; Assigned to Arm(s): Robotic Assisted Laparoscopic (RASC) | Intervention Type: PROCEDURE; Name: Standard laparoscopic abdominal sacrocolpopexy; Assigned to Arm(s): Laparoscopic Abdominal Sacrocolpopexy (LASC)
B: Intervention Type: PROCEDURE; Name: sacral colpopexy; Assigned to Arm(s): N/A
C: Arm Label: Interrupted suture; Type: ACTIVE_COMPARATOR; Interventions: Device: Device is the type of suture used: Quill suture vs. Interrupted suture | Arm Label: Quill suture; Type: ACTIVE_COMPARATOR; Interventions: Device: Device is the type of suture used: Quill suture vs. Interrupted suture | Intervention Type: DEVICE; Name: Device is the type of suture used: Quill suture vs. Interrupted suture; Assigned to Arm(s): Interrupted suture, Quill suture
D: Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: robotic laparoscopic sacrocolpopexy | Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Laparoscopic Sacral Colpopexy | Intervention Type: PROCEDURE; Name: robotic laparoscopic sacrocolpopexy; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Laparoscopic Sacral Colpopexy; Assigned to Arm(s): 1

Answer: C