Anchor for Robotic Sacrocolpopexy
Status unconfirmed · Phase 3
Conditions studied: Pelvic Organ Prolapse
In brief
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
Key facts
- Study ID
- NCT03378622
- Run by
- Kaiser Permanente
- People needed
- 53
- Starts
- 2017-11-29
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2019-03-06
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Kaiser Permanent San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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