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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Kaiser Permanent San Diego
San Diego, California, United States
Mesh Attachment Time
Mesh Attachment Time
Time frame: Assessed at one time point, during the participants surgery.
Perioperative Complications
Perioperative Complications
Time frame: Assessed at one time point, during the participants surgery.
Postoperative Complications
Postoperative Complications
Time frame: Assessed at two time points, 6 weeks and 6 months postoperatively
Surgeon Satisfaction
Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction
Time frame: Assessed at one time point, during the participants surgery.
Surgical Failure
Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.
Time frame: Assessed at two time points, 6 weeks and 6 months postoperatively
Vaginal wall appearance
Vaginal wall appearance assessed using a using a visual analog scale (10 point)assessment of overall appearance as well as sub-categories of anterior and posterior walls.
Time frame: Assessed at two time points, 6 weeks and 6 months postoperatively
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