ARiSe: Anchor for Robotic Sacrocolpopexy
Study Details
Study Description
Brief Summary
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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.
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SECONDARY OBJECTIVES:
- 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anchor Anchor used for mesh attachment |
Other: Anchor
Anchor technique for mesh attachment
|
| Active Comparator: Suture Suture used for mesh attachment |
Other: Suture
Suture technique for mesh attachment
|
Outcome Measures
Primary Outcome Measures
- Mesh Attachment Time [Assessed at one time point, during the participants surgery.]
Mesh Attachment Time
Secondary Outcome Measures
- Perioperative Complications [Assessed at one time point, during the participants surgery.]
Perioperative Complications
- Postoperative Complications [Assessed at two time points, 6 weeks and 6 months postoperatively]
Postoperative Complications
- Surgeon Satisfaction [Assessed at one time point, during the participants surgery.]
Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction
- Surgical Failure [Assessed at two time points, 6 weeks and 6 months postoperatively]
Surgical Failure assessed using the pelvic organ prolapse quantification scoring system.
- Vaginal wall appearance [Assessed at two time points, 6 weeks and 6 months postoperatively]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 21 or older
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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'
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Desire surgical treatment for POP with SCP
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Available for up to 6 months of follow up
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Not pregnant or desiring future pregnancy
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Written informed consent is obtained.
Exclusion Criteria:
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Known adverse reaction to synthetic mesh, or complications including but not limited to erosion, fistula, or abscess.
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Cervical intraepithelial neoplasia (cervical intraepithelial neoplasia (CIN) 2, CIN3, or cancer)
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Unresolved chronic pelvic pain
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Prior abdominal or pelvic radiation
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Contraindications to the surgical procedures including known horseshoe kidney, pelvic abscess or active diverticular abscess or diverticulitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanent San Diego | San Diego | California | United States | 92110 |
Sponsors and Collaborators
- Kaiser Permanente
- University of California, San Diego
Investigators
- Study Director: Alexander A Berger, Kaiser Permanente
- Principal Investigator: Shawn A Menefee, MD, Kaiser Permanente
Study Documents (Full-Text)
More Information
Publications
None provided.- 11460