Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
Brief Summary: Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of surgical treatment when indicated.

Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success. Despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years .

It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Short term data from concluded and on-going safety assessments of these techniques has provided promising results and satisfying clinical outcomes. The aim of the present study is to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised trial.


Options:
A: Arm Label: Anterior colporrhaphy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: anterior vaginal repair (colporrhaphy), Procedure: abdominal paravaginal defect repair | Arm Label: Paravaginal defect repair; Type: ACTIVE_COMPARATOR; Interventions: Procedure: anterior vaginal repair (colporrhaphy), Procedure: abdominal paravaginal defect repair | Intervention Type: PROCEDURE; Name: anterior vaginal repair (colporrhaphy); Assigned to Arm(s): Anterior colporrhaphy, Paravaginal defect repair | Intervention Type: PROCEDURE; Name: abdominal paravaginal defect repair; Assigned to Arm(s): Anterior colporrhaphy, Paravaginal defect repair
B: Arm Label: Mesh surgery; Type: EXPERIMENTAL; Interventions: Device: Tensionfree vaginal mesh kit (Prolift) | Arm Label: Conventional vaginal surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: classic vaginal prolapse surgery (fascia plication) | Intervention Type: DEVICE; Name: Tensionfree vaginal mesh kit (Prolift); Assigned to Arm(s): Mesh surgery | Intervention Type: PROCEDURE; Name: classic vaginal prolapse surgery (fascia plication); Assigned to Arm(s): Conventional vaginal surgery
C: Intervention Type: DEVICE; Name: Low-weight prolypropylene mesh; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Anterior colporrhaphy | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Procedure: Anterior PROLIFT | Intervention Type: PROCEDURE; Name: Anterior colporrhaphy; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Anterior PROLIFT; Assigned to Arm(s): 2

Answer: D