Anchor for Robotic Sacrocolpopexy

Phase 3

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Suture; Other: Anchor

• Registration Number: NCT03378622
• Lead Sponsor: Kaiser Permanente

Brief 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.

Study Timeline

• Study Start: 2017-11-29
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• Age 21 or older
• Diagnosis of POP, defined as the descent of one or more of four different anatomic structures, a)the uterus(cervix), b)the apex of the vagina (in those status post hysterectomy) c) the anterior vaginal wall, or d) the posterior vaginal wall. This is defined on exam as the POPQ points Ba, C, or Bp >0 cm beyond the hymen, uterine(cervix) descent into at least the lower half the vagina (defined as point c> -tvl/2) or post hysterectomy vault into the lower 2/3 of the vagina. Bothersome bulge symptoms as indicated on question 3 of the Pelvic Floor Disorder Inventory (PFDI-20) form relating to 'sensation of bulging' or something 'falling out'
• Desire surgical treatment for POP with SCP
• Available for up to 6 months of follow up
• Not pregnant or desiring future pregnancy
• Written informed consent is obtained.

Exclusion Criteria

• Known adverse reaction to synthetic mesh, or complications including but not limited to erosion, fistula, or abscess.
• Cervical intraepithelial neoplasia (cervical intraepithelial neoplasia (CIN) 2, CIN3, or cancer)
• Unresolved chronic pelvic pain
• Prior abdominal or pelvic radiation
• Contraindications to the surgical procedures including known horseshoe kidney, pelvic abscess or active diverticular abscess or diverticulitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Suture	Suture used for mesh attachment
Anchor	Anchor	Anchor used for mesh attachment

Primary Outcome Measures

Name	Time	Method
Mesh Attachment Time	Assessed at one time point, during the participants surgery.	Mesh Attachment Time

Secondary Outcome Measures

Name	Time	Method
Perioperative Complications	Assessed at one time point, during the participants surgery.	Perioperative Complications
Vaginal wall appearance	Assessed at two time points, 6 weeks and 6 months postoperatively	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.
Surgical Failure	Assessed at two time points, 6 weeks and 6 months postoperatively	Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.
Postoperative Complications	Assessed at two time points, 6 weeks and 6 months postoperatively	Postoperative Complications
Surgeon Satisfaction	Assessed at one time point, during the participants surgery.	Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction

Trial Locations

Locations (1)

Kaiser Permanent San Diego; 🇺🇸 San Diego, California, United States