Anchor for Robotic Sacrocolpopexy (ARiSe)

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

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

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Anchor; Other: Suture

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92110
      • Kaiser Permanent San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anchor; Anchor used for mesh attachment	Other: Anchor; Anchor technique for mesh attachment
ACTIVE_COMPARATOR: Suture; Suture used for mesh attachment	Other: Suture; Suture technique for mesh attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesh Attachment Time	Mesh Attachment Time	Assessed at one time point, during the participants surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Complications	Perioperative Complications	Assessed at one time point, during the participants surgery.
Postoperative Complications	Postoperative Complications	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	Assessed at one time point, during the participants surgery.
Surgical Failure	Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.	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.	Assessed at two time points, 6 weeks and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of California, San Diego
• Investigators: Study Director: Alexander A Berger, Kaiser Permanente; Principal Investigator: Shawn A Menefee, MD, Kaiser Permanente

Publications and helpful links

General Publications

• Berger AA, Tan-Kim J, Menefee SA. Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial. Am J Obstet Gynecol. 2020 Aug;223(2):258.e1-258.e8. doi: 10.1016/j.ajog.2020.05.018. Epub 2020 May 13.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2017
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 11460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No