Status:
UNKNOWN
Anchor for Robotic Sacrocolpopexy
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
University of California, San Diego
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Phase:
PHASE3
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 p...
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 anchor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03378622
Start Date
November 29 2017
End Date
January 1 2020
Last Update
March 6 2019
Active Locations (1)
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1
Kaiser Permanent San Diego
San Diego, California, United States, 92110