HysterectomyPhase 2NCT02998658
Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
A Phase 2 study testing Vaginal cuff closure using barbed sutures and Vaginal cuff closure using conventional sutures in people with Hysterectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Vaginal cuff closure using barbed sutures and Vaginal cuff closure using conventional sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2017to Feb 2019
- Phase
- Phase 2
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)
Who cannot join
- Genital malignancy
- Uterine size more than 16 weeks
- Coagulation defects or concurrent anticoagulant therapy
- Pregnancy
- Compromised cardiopulmonary status
- Contraindications for general anesthesia
Trial locations and contacts
1 site in 1 country.
Usama M Fouda, Prof. contact
Khaled A Elsetohy,, Prof. contact
About this study
Official title: Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial
The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.
Read the detailed description
Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (0.3-3.1 %) compared to abdominal and vaginal hysterectomy
Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When compared with conventional smooth suture, barbed suture has external barbs that anchor the suture to the tissues and prevent the retrograde movement of suture thread during suturing. Consequently, laparoscopic suturing can be performed easily without the need for suture locking, without applying traction on suture thread by the assistant and without tying knots at both ends of the suture line In gynecology, barbed sutures have been used in minimally invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic suturing and significantly reduces suturing time, total operating time and intraoperative blood loss To date only two small randomized controlled trials compared the effectiveness of the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff
- Conditions
- Hysterectomy
- Being tested
- Vaginal cuff closure using barbed sutures, Vaginal cuff closure using conventional sutures
- Keywords
- Laparoscopy, Barbed sutures, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal cuff closure using barbed suturesDevice
Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )
Vaginal cuff closure using conventional suturesDevice
Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
| Study group | Role | What they receive |
|---|---|---|
| Vaginal cuff closure using barbed sutures | Experimental | Vaginal cuff is closed with barbed sutures Receives: Device: Vaginal cuff closure using barbed sutures |
| Vaginal cuff closure using conventional sutures | Active comparator | Vaginal cuff is closed with conventional sutures Receives: Device: Vaginal cuff closure using conventional sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing time of vaginal cuff
Measured: During hysterectomy operation
Secondary outcomes (1)
Operative time
Measured: During hysterectomy operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startFeb 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama M Fouda, Cairo University
- Investigators
- Usama M Fouda, Prof., Study director, Cairo university ,Faculty of medicine , Obstetrics and Gynecology DepartmentKhaled A Elsetohy,, Prof., Principal investigator, Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998658
- Sponsor's protocol ID
- Barbed/vaginal cuff
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.
PubMed 23680517
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02998658
- Acronym / sponsor ID
- Barbed/vaginal cuff
- Conditions
- Hysterectomy
- Keywords
- Laparoscopy, Barbed sutures, Hysterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 20 Dec 2016 (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.
The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.
Detailed description
Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (0.3-3.1 %) compared to abdominal and vaginal hysterectomy
Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When compared with conventional smooth suture, barbed suture has external barbs that anchor the suture to the tissues and prevent the retrograde movement of suture thread during suturing. Consequently, laparoscopic suturing can be performed easily without the need for suture locking, without applying traction on suture thread by the assistant and without tying knots at both ends of the suture line In gynecology, barbed sutures have been used in minimally invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic suturing and significantly reduces suturing time, total operating time and intraoperative blood loss To date only two small randomized controlled trials compared the effectiveness of the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal cuff closure using barbed sutures | Experimental | Device: Vaginal cuff closure using barbed suturesVaginal cuff is closed with barbed sutures |
| Vaginal cuff closure using conventional sutures | Active comparator | Device: Vaginal cuff closure using conventional suturesVaginal cuff is closed with conventional sutures |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)
Key exclusion criteria (6 listed)
- Genital malignancy
- Uterine size more than 16 weeks
- Coagulation defects or concurrent anticoagulant therapy
- Pregnancy
- Compromised cardiopulmonary status
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 |
|---|---|---|
| Vaginal cuff closure using barbed suturesVaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ) | Device | Vaginal cuff closure using barbed sutures |
| Vaginal cuff closure using conventional suturesVaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) . | Device | Vaginal cuff closure using conventional sutures |
Primary outcome
Suturing time of vaginal cuff
Time frame: During hysterectomy operation
1 secondary outcome
Operative time
Time frame: During hysterectomy operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Background: PubMed 23680517Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.
- Individual participant dataSharing planned: No
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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.
Usama M Fouda, Prof. contact
Khaled A Elsetohy,, Prof. contact
Usama M Fouda, Prof. study director
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Khaled A Elsetohy,, Prof. principal investigator
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal cuff closure using barbed sutures and Vaginal cuff closure using conventional sutures in people with Hysterectomy, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 6 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Usama M Fouda, Prof. (umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suturing time of vaginal cuff (time frame: During hysterectomy operation). 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 NCT02998658, which also lists 1 linked publication.
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 20 Dec 2016.