NCT03378622

Anchor for Robotic Sacrocolpopexy

The Use of Anchor Versus Suturing for Attachment of Vaginal Mesh in Minimally Invasive Sacrocolpopexy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure. 2. SECONDARY OBJECTIVES: i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance

Detailed description

By applying a commonly used surgical technique of absorbable anchors to a new surgery, Sacrocolpopexy (SCP), operative time may be decreased while providing similar patient outcomes. Absorbable anchors have been validated in mesh fixation during laparoscopic surgical repair of hernias. This technique potentially takes less time than traditional suturing, thus decreasing cost and morbidity of anesthesia. The investigators hypothesis proposes that for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will require 50% shorter surgical time for the mesh attachment portion of the surgery. The investigators secondary hypothesis is for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will have similar rates of intra-operative and post-operative complications and surgical failure. On VAS, patients will not have different appearance of the vaginal walls. Surgeons will report higher satisfaction with the anchor technique.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	Anchor	Anchor technique for mesh attachment
OTHER	Suture	Suture technique for mesh attachment

Timeline

• Start date: 2017-11-29
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2017-12-20
• Last updated: 2019-03-06

Locations

1 site across 1 country: United States