NCT03378622

Brief Summary

  1. 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. 2.SECONDARY OBJECTIVES:

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

December 4, 2017

Last Update Submit

March 4, 2019

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Mesh Attachment Time

    Mesh Attachment Time

    Assessed at one time point, during the participants surgery.

Secondary Outcomes (5)

  • Perioperative Complications

    Assessed at one time point, during the participants surgery.

  • Postoperative Complications

    Assessed at two time points, 6 weeks and 6 months postoperatively

  • Surgeon Satisfaction

    Assessed at one time point, during the participants surgery.

  • Surgical Failure

    Assessed at two time points, 6 weeks and 6 months postoperatively

  • Vaginal wall appearance

    Assessed at two time points, 6 weeks and 6 months postoperatively

Study Arms (2)

Anchor

EXPERIMENTAL

Anchor used for mesh attachment

Other: Anchor

Suture

ACTIVE COMPARATOR

Suture used for mesh attachment

Other: Suture

Interventions

AnchorOTHER

Anchor technique for mesh attachment

Anchor
SutureOTHER

Suture technique for mesh attachment

Suture

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanent San Diego

San Diego, California, 92110, United States

Location

Related Publications (1)

  • 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.

    PMID: 32413431DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Sutures

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Alexander A Berger

    Kaiser Permanente

    STUDY DIRECTOR

  • Shawn A Menefee, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 20, 2017

Study Start

November 29, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)