Anchorsure Versus Capio for Sacrospinous Ligament Fixation
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/4/2018 |
| Start Date: | October 29, 2018 |
| End Date: | August 2019 |
| Contact: | Andre R Plair, MD |
| Email: | aplair@wakehealth.edu |
| Phone: | 336-716-4310 |
Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic
organ prolapse but it currently suffers from a high rate of postoperative buttock and
posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor
instead of the widely-used suture capturing mechanism to perform sacrospinous ligament
fixation. The study hypothesis is that Anchorsure® will reduce the degree and rate of buttock
and posterior thigh pain compared to the widely used Capio™ Slim suturing capturing Device.
organ prolapse but it currently suffers from a high rate of postoperative buttock and
posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor
instead of the widely-used suture capturing mechanism to perform sacrospinous ligament
fixation. The study hypothesis is that Anchorsure® will reduce the degree and rate of buttock
and posterior thigh pain compared to the widely used Capio™ Slim suturing capturing Device.
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic
organ prolapse but it currently suffers from a high rate of postoperative buttock and
posterior thigh pain. Rates of buttock and thigh pain 6 weeks after sacrospinous ligament
fixation with the widely used Capio™ Slim device (Boston Scientific) are about 15-16% with
immediate postoperative pain occurring in 55-84% of patients. This study is a randomized
controlled single-blind study with the primary goal of investigating if there is an
improvement in the intensity and rate of buttock and posterior thigh pain 1 day, 7 days, and
6 weeks after sacrospinous ligament fixation with a new device, the Anchorsure® Suture
Anchoring System (Neomedic) compared to the widely utilized Capio™ Slim (Boston Scientific)
device. 60 patients will be enrolled to undergo sacrospinous ligament fixation for treatment
of pelvic organ prolapse. The patients will be randomized into two study groups; one will
have sacrospinous ligament fixation using the Capio™ Slim device and the other with the
Anchorsure® device. The patient's pain will be recorded via the numerical rating scale (NRS),
a validated pain evaluation tool. The study is powered to detect a 2.5 point difference in
pain between the two groups, a value that has been shown in studies to be clinically
significant to acute pain patients. Secondary outcomes of surgeon satisfaction and efficiency
with the devices will be assessed via surgeon questionnaires.
organ prolapse but it currently suffers from a high rate of postoperative buttock and
posterior thigh pain. Rates of buttock and thigh pain 6 weeks after sacrospinous ligament
fixation with the widely used Capio™ Slim device (Boston Scientific) are about 15-16% with
immediate postoperative pain occurring in 55-84% of patients. This study is a randomized
controlled single-blind study with the primary goal of investigating if there is an
improvement in the intensity and rate of buttock and posterior thigh pain 1 day, 7 days, and
6 weeks after sacrospinous ligament fixation with a new device, the Anchorsure® Suture
Anchoring System (Neomedic) compared to the widely utilized Capio™ Slim (Boston Scientific)
device. 60 patients will be enrolled to undergo sacrospinous ligament fixation for treatment
of pelvic organ prolapse. The patients will be randomized into two study groups; one will
have sacrospinous ligament fixation using the Capio™ Slim device and the other with the
Anchorsure® device. The patient's pain will be recorded via the numerical rating scale (NRS),
a validated pain evaluation tool. The study is powered to detect a 2.5 point difference in
pain between the two groups, a value that has been shown in studies to be clinically
significant to acute pain patients. Secondary outcomes of surgeon satisfaction and efficiency
with the devices will be assessed via surgeon questionnaires.
Inclusion Criteria:
- Female patients
- At least 21 years of age
- Surgical plan that includes a native tissue vaginal repair with apical support via
sacrospinous ligament fixation. We will permit both hysteropexy and post-hysterectomy
sacrospinous ligament suspension
- Understanding and acceptance of the need to return for the 6 week follow-up visit
- English speaking and able to give informed consent
- Willing and able to complete all study questionnaires
- Ambulatory
Exclusion Criteria:
- Prior sacrospinous ligament fixation procedure.
- Any serious disease or chronic condition that could interfere with the study
compliance
- Inability to give informed consent
- Pregnancy or planning pregnancy prior to the 6 week postoperative visit
- Prior pelvic radiation
- Incarcerated
- Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse
repair
- History of significant buttock or leg pain in the past 3 months
- History of fibromyalgia, polymyositis, dermatomyositis, systemic lupus erythematosus,
or other auto-immune myalgic conditions
- Current regular opioid drug therapy for any chronic pain condition
- History of loss of motor or sensory function of the lower extremities
- History of sacral decubitus ulcers
- Planned concomitant levatorplasty; anal sphincteroplasty, anal fissurectomy,
rectopexy, or hemorrhoidectomy
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: Catherine Matthews, MD
Phone: 336-716-4310
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