Postoperative Pain Clinical Trial
Official title:
Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.
Verified date | September 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | January 26, 2022 |
Est. primary completion date | January 26, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Buttock and Posterior Thigh Pain | This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain. | postoperative 12 month | |
Secondary | POP-Q Stage Score | The stage is assigned as follows: 0 if there is no prolapse at all, 1 if there is prolapse but the leading point is not within 1cm of the hymen, 2 if the leading point is within 1 cm of the hymen (from 1cm within the hymen to 1cm beyond the hymen), 3 if the leading point is more than 1cm from the hymen but less than 2cm from being completely prolapsed, and 4 if the leading point is within 2cm of being complete prolapsed. Therefore higher POP-Q stages correlate to a worse degree of prolapse than lower POP-Q stages. | at 12 MONTHS | |
Secondary | Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months | Symptomatic success was assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 sub-scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each sub-scale is multiplied by 25 to obtain the sub-scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms. |
Baseline and Month 12 | |
Secondary | Change in Symptomatic Success - PFIQ-7 Scores | Symptomatic success will be assessed by the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7). The PFIQ-7 has 7 items for each of 3 sub-scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each sub-scale is multiplied by 100/3 to obtain the total scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms. |
Baseline and Month 12 |
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