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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anchor | Experimental | Anchor used for mesh attachment |
|
| Suture | Active Comparator | Suture used for mesh attachment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anchor | Other | Anchor technique for mesh attachment |
| |
| Suture |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh Attachment Time | Mesh Attachment Time | Assessed at one time point, during the participants surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Complications | Perioperative Complications | Assessed at one time point, during the participants surgery. |
| Postoperative Complications | Postoperative Complications |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Alexander A Berger | Kaiser Permanente | Study Director |
| Shawn A Menefee, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanent San Diego | San Diego | California | 92110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32413431 | Derived | Berger AA, Tan-Kim J, Menefee SA. Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial. Am J Obstet Gynecol. 2020 Aug;223(2):258.e1-258.e8. doi: 10.1016/j.ajog.2020.05.018. Epub 2020 May 13. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2017 | Dec 13, 2017 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 21, 2017 | Dec 18, 2017 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2017 | Dec 18, 2017 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Other |
Suture technique for mesh attachment |
|
| Assessed at two time points, 6 weeks and 6 months postoperatively |
| Surgeon Satisfaction | Surgeon Satisfaction assessed using a visual analog scale (10 point)assessment of satisfaction | Assessed at one time point, during the participants surgery. |
| Surgical Failure | Surgical Failure assessed using the pelvic organ prolapse quantification scoring system. | Assessed at two time points, 6 weeks and 6 months postoperatively |
| Vaginal wall appearance | 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. | Assessed at two time points, 6 weeks and 6 months postoperatively |