Disease (or Disorder); GynecologicalNCT01814579
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
A study testing Unidirectional Barbed Suture (V-Loc) and polyglactin 910 (Vicryl) in people with Disease (or Disorder); Gynecological, run by University of Tennessee at 2 sites in United States.
Trial summary
This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Disease (or Disorder); Gynecological
- What is being tested?
- Unidirectional Barbed Suture (V-Loc) and polyglactin 910 (Vicryl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
- Females age 18+
Who cannot join
- Patients receiving ongoing radiation therapy to the pelvis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methodist University Hospital
Memphis, Tennessee, 38103
The West Clinic
Memphis, Tennessee, 38120
About this study
Official title: Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy, a Randomized Controlled Trial
This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.
Read the detailed description
Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.
- Conditions
- Disease (or Disorder); Gynecological
- Being tested
- Unidirectional Barbed Suture (V-Loc), polyglactin 910 (Vicryl)
- Keywords
- vaginal, cuff, robotic, hysterectomy, vloc, v-loc, vicryl, unidirectional, barbed, suture
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unidirectional Barbed Suture (V-Loc)Device
Also called V-Loc Wound Closure System
Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.
polyglactin 910 (Vicryl)Device
Also called Vicryl
Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| V-Loc Vaginal Cuff Closure | Experimental | Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy. Receives: Device: Unidirectional Barbed Suture (V-Loc) |
| Vicryl Vaginal Cuff Closure | Active comparator | Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy. Receives: Device: polyglactin 910 (Vicryl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Cuff Closure Time
Vaginal cuff closure time will be timed at time of robotic hysterectomy.
Measured: At time of surgery
Secondary outcomes (3)
Vaginal Cuff Dehiscence
Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff dehiscence has occurred and will be again screened by phone 3 months post operatively.
Measured: Post Operatively (3 months)
Vaginal Cuff Evisceration
Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff evisceration has occurred and will be again screened by phone 3 months post operatively.
Measured: Post Operatively (3 months)
Vaginal Cuff Granulation Tissue Formation
Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff granulation tissue formation has occurred and will be again screened by phone 3 months post operatively.
Measured: Post Operatively (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disease (or Disorder); GynecologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist LeBonheur Hospital System, The West Clinic
- Responsible party
- Principal investigator, Adam Mabe, University of Tennessee
- Investigators
- Todd Tillmanns, MD, Principal investigator, University of Tennessee, The West ClinicAdam Mabe, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814579
- Sponsor's protocol ID
- 11-01423-FB
- Other IDs
- 12-14
- Status last verified
- Mar 2013
- First submitted
- 16 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradshaw AD, Advincula AP. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Dec;114(6):1372. doi: 10.1097/AOG.0b013e3181c3f60f. No abstract available.
PubMed 19935045Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
PubMed 21354068Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
PubMed 21333192Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
PubMed 21364859
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01814579
- Acronym / sponsor ID
- 11-01423-FB
- Conditions
- Disease (or Disorder); Gynecological
- Keywords
- vaginal, cuff, robotic, hysterectomy, vloc, v-loc, vicryl, unidirectional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Methodist LeBonheur Hospital System, The West Clinic
- Study start
- Jul 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.
Detailed description
Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V-Loc Vaginal Cuff Closure | Experimental | Device: Unidirectional Barbed Suture (V-Loc)Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy. |
| Vicryl Vaginal Cuff Closure | Active comparator | Device: polyglactin 910 (Vicryl)Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
- Females age 18+
Key exclusion criteria (1 listed)
- Patients receiving ongoing radiation therapy to the pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unidirectional Barbed Suture (V-Loc)Also: V-Loc Wound Closure SystemPatients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy. | Device | V-Loc Vaginal Cuff Closure |
| polyglactin 910 (Vicryl)Also: VicrylPatients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy. | Device | Vicryl Vaginal Cuff Closure |
Primary outcome
Vaginal Cuff Closure Time
Time frame: At time of surgery
Vaginal cuff closure time will be timed at time of robotic hysterectomy.
3 secondary outcomes
Vaginal Cuff Dehiscence
Time frame: Post Operatively (3 months)
Vaginal Cuff Evisceration
Time frame: Post Operatively (3 months)
Vaginal Cuff Granulation Tissue Formation
Time frame: Post Operatively (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
- Background: PubMed 19935045Bradshaw AD, Advincula AP. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Dec;114(6):1372. doi: 10.1097/AOG.0b013e3181c3f60f. No abstract available.
- Background: PubMed 21354068Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
- Background: PubMed 21333192Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
- Background: PubMed 21364859Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
- V-Loc Wound Closure Device Device InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Tillmanns, MD principal investigator
University of Tennessee, The West Clinic
Adam Mabe, MD principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unidirectional Barbed Suture (V-Loc) and polyglactin 910 (Vicryl) in people with Disease (or Disorder); Gynecological, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Cuff Closure Time (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814579, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.