Anchorsure Versus Capio for Sacrospinous Ligament Fixation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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, 6 weeks, and minimum 12 months 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03565640
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	N/A
Start date	October 29, 2018
Completion date	January 26, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT03181620` - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Recruiting	`NCT06007378` - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery	N/A
Recruiting	`NCT05943015` - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks	N/A
Completed	`NCT04544228` - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy	N/A
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT03663478` - Continuous TQL Block for Elective Cesarean Section	Phase 4
Completed	`NCT04176822` - Designing Animated Movie for Preoperative Period	N/A
Completed	`NCT05170477` - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment	N/A
Not yet recruiting	`NCT04561856` - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone	Phase 4
Completed	`NCT03612947` - TAP Block in Laparoscopic Cholecystectomy.	Phase 2
Recruiting	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05995912` - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain	Phase 2
Completed	`NCT04571515` - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain	Phase 2
Active, not recruiting	`NCT04190355` - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain	N/A
Recruiting	`NCT05145153` - Incidence of Chronic Pain After Thoracic Surgery
Recruiting	`NCT03697278` - Monitoring Postoperative Patient-controlled Analgesia (PCA)	N/A
Completed	`NCT03650998` - Transmuscular Quadratus Lumborum Block for Total Laparoscopic Hysterectomy.	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.