Anchor for Robotic Sacrocolpopexy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/8/2019 |
| Start Date: | November 29, 2017 |
| End Date: | January 1, 2020 |
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
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
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.
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.
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
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