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Anchor for Robotic Sacrocolpopexy (ARiSe)

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anchor
Suture
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanent San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anchor

Suture

Arm Description

Anchor used for mesh attachment

Suture used for mesh attachment

Outcomes

Primary Outcome Measures

Mesh Attachment Time
Mesh Attachment Time

Secondary Outcome Measures

Perioperative Complications
Perioperative Complications
Postoperative Complications
Postoperative Complications
Surgeon Satisfaction
Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction
Surgical Failure
Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.
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.

Full Information

First Posted
December 4, 2017
Last Updated
March 4, 2019
Sponsor
Kaiser Permanente
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03378622
Brief Title
Anchor for Robotic Sacrocolpopexy
Acronym
ARiSe
Official Title
The Use of Anchor Versus Suturing for Attachment of Vaginal Mesh in Minimally Invasive Sacrocolpopexy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anchor
Arm Type
Experimental
Arm Description
Anchor used for mesh attachment
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
Suture used for mesh attachment
Intervention Type
Other
Intervention Name(s)
Anchor
Intervention Description
Anchor technique for mesh attachment
Intervention Type
Other
Intervention Name(s)
Suture
Intervention Description
Suture technique for mesh attachment
Primary Outcome Measure Information:
Title
Mesh Attachment Time
Description
Mesh Attachment Time
Time Frame
Assessed at one time point, during the participants surgery.
Secondary Outcome Measure Information:
Title
Perioperative Complications
Description
Perioperative Complications
Time Frame
Assessed at one time point, during the participants surgery.
Title
Postoperative Complications
Description
Postoperative Complications
Time Frame
Assessed at two time points, 6 weeks and 6 months postoperatively
Title
Surgeon Satisfaction
Description
Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction
Time Frame
Assessed at one time point, during the participants surgery.
Title
Surgical Failure
Description
Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.
Time Frame
Assessed at two time points, 6 weeks and 6 months postoperatively
Title
Vaginal wall appearance
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander A Berger
Organizational Affiliation
Kaiser Permanente
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shawn A Menefee, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanent San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32413431
Citation
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.
Results Reference
derived

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Anchor for Robotic Sacrocolpopexy

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