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Suture
Barbed Sutures for Uterine Prolapse (BEST Trial)
N/A
Recruiting
Led By Katherine L Woodburn, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
BEST Trial Summary
This trial shows minimally invasive SCP is associated with improved outcomes, but requires longer operating time. Attaching the vaginal mesh takes a lot of time.
Who is the study for?
This trial is for English-speaking women over 21 with bothersome vaginal bulge, eligible for laparoscopic or robotic sacrocolpopexy due to uterine prolapse. They must not have poorly controlled diabetes, be unable to maintain certain positions during surgery, or have medical conditions preventing surgery. Women who've had prior mesh repairs or pelvic organ cancer, those on recent steroids/immunosuppressants, and with sensitivity to polypropylene are excluded.Check my eligibility
What is being tested?
The study compares two types of sutures used in minimally invasive sacrocolpopexy: non-barbed delayed absorbable suture versus barbed delayed absorbable suture. The goal is to see if one results in faster operation times without compromising patient outcomes like recovery speed and hospital stay duration.See study design
What are the potential side effects?
Potential side effects may include discomfort at the suture site, infection risk from the procedure itself, bleeding complications related to surgery, possible allergic reactions if sensitive to materials used in sutures (polypropylene), and general surgical risks such as pain and slower recovery.
BEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to complete vaginal graft attachment
Secondary outcome measures
Adverse outcome scores
Composite success rate
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
+4 moreOther outcome measures
Mesh related adverse events and surgical success compared to PACT trial
BEST Trial Design
2Treatment groups
Experimental Treatment
Group I: Non-barbed delayed absorbable sutureExperimental Treatment1 Intervention
Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
Group II: Barbed delayed absorbable sutureExperimental Treatment1 Intervention
Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,678 Total Patients Enrolled
Katherine L Woodburn, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or participate in the study procedures.I do not have any active infections, including UTIs or tissue necrosis.I need surgery to fix a rectal prolapse.I want surgery for my prolapse symptoms.I am scheduled for a procedure to place vaginal mesh through the vagina.I cannot lie in a steep head-down position.My diabetes is not well-managed, with an A1c level over 9.I have not taken systemic steroids or immunosuppressive treatments recently.I have had or am having radiation, laser, or chemo in my pelvic area.I have a prolapse that extends to or beyond the vaginal opening.I have had cancer in my pelvic organs.I cannot have surgery because of other health problems.I have a systemic connective tissue disease like lupus or scleroderma.I have had surgery for prolapse with mesh before.I have had diverticulitis in the past.I am 21 years old or older.I am a candidate for minimally invasive pelvic organ prolapse surgery.I have long-term pain in my pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Barbed delayed absorbable suture
- Group 2: Non-barbed delayed absorbable suture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the ability to register for this research initiative?
"Eligibility criteria for this research project include a diagnosis of uterine prolapse and an age range between 21 to 80 years old. A total of 52 volunteers are sought after."
Answered by AI
Are elderly participants being considered for this investigation?
"As detailed in the inclusion criteria, those hoping to join this medical trial must be from 21-80 years old. Additionally, there are 4 trials available for those under 18 and 78 separate ones open to individuals 65 or older."
Answered by AI
Are there any remaining vacancies in this medical trial?
"Evidence on clinicaltrials.gov reveals that this medical trial is not presently seeking participants, as the study was last updated in February of 2023. Needless to say, there are 83 other trials actively recruiting patients at present time."
Answered by AI
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