Anchor for Robotic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

— ARiSe  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03378622
• Other study ID #: 11460
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 29, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Anchor
Anchor technique for mesh attachment
• Suture
Suture technique for mesh attachment

Locations

Country	Name	City	State
United States	Kaiser Permanent San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesh Attachment Time	Mesh Attachment Time	Assessed at one time point, during the participants surgery.
Secondary	Perioperative Complications	Perioperative Complications	Assessed at one time point, during the participants surgery.
Secondary	Postoperative Complications	Postoperative Complications	Assessed at two time points, 6 weeks and 6 months postoperatively
Secondary	Surgeon Satisfaction	Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction	Assessed at one time point, during the participants surgery.
Secondary	Surgical Failure	Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.	Assessed at two time points, 6 weeks and 6 months postoperatively
Secondary	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.	Assessed at two time points, 6 weeks and 6 months postoperatively