FibroidPhase 2NCT02166411
Laparoscopic Myomectomy Using Barbed or Conventional Sutures
A Phase 2 study testing myomectomy using barbed sutures and myomectomy using conventional sutures in people with Fibroid, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures . Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fibroid
- What is being tested?
- myomectomy using barbed sutures and myomectomy using conventional sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Jan 2020
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
Who cannot join
- submucosal myoma
- calcified myomas
- uterine size more than 16 weeks
- suspension of genital malignancy
- coagulation defects or concurrent anticoagulant therapy
- pregnancy
Show all 9Show fewer
- compromised cardiopulmonary status
- previous treatment with gonadotropin-releasing hormone analogue
- contraindications for general anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Cairo
About this study
Official title: Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .
Read the detailed description
- Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .
- Conditions
- Fibroid
- Being tested
- myomectomy using barbed sutures, myomectomy using conventional sutures
- Keywords
- Myomectomy ,Laparoscopy , Barbed sutures
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomectomy using barbed suturesProcedure or surgery
A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by 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 ).
myomectomy using conventional suturesProcedure or surgery
A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ)
| Study group | Role | What they receive |
|---|---|---|
| myomectomy using barbed sutures | Experimental | .Myoma bed is sutured with barbed sutures Receives: Procedure: myomectomy using barbed sutures |
| myomectomy using conventional sutures | Active comparator | Myoma bed is sutured with conventional sutures Receives: Procedure: myomectomy using conventional sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: During myomectomy operation
Secondary outcomes (1)
Suturing time of myoma bed
Measured: During myomectomy operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionJan 2020
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 FibroidStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama M Fouda, Cairo University
- Investigators
- Mohamed Zayed, M.D,PhD, Study chair, Cairo university ,Faculty of medicine , Obstetrics and Gynecology DepartmentUsama M Fouda, M.D,PhD, Study director, Cairo university ,Faculty of medicine , Obstetrics and Gynecology DepartmentKhaled A Elsetohy, M.D,PhD, Principal investigator, Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166411
- Sponsor's protocol ID
- lap.myomectomy
- Status last verified
- Oct 2019
- First submitted
- 16 Jun 2014
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
PubMed 18619922
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02166411
- Acronym / sponsor ID
- lap.myomectomy
- Conditions
- Fibroid
- Keywords
- Myomectomy ,Laparoscopy , Barbed sutures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 18 Jun 2014 (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 compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .
Detailed description
- Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myomectomy using barbed sutures | Experimental | Procedure: myomectomy using barbed sutures.Myoma bed is sutured with barbed sutures |
| myomectomy using conventional sutures | Active comparator | Procedure: myomectomy using conventional suturesMyoma bed is sutured with conventional sutures |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
Key exclusion criteria (9 listed)
- submucosal myoma
- calcified myomas
- uterine size more than 16 weeks
- suspension of genital malignancy
- coagulation defects or concurrent anticoagulant therapy
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 |
|---|---|---|
| myomectomy using barbed suturesA transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by 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 ). | Procedure or surgery | myomectomy using barbed sutures |
| myomectomy using conventional suturesA transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) | Procedure or surgery | myomectomy using conventional sutures |
Primary outcome
Operative time
Time frame: During myomectomy operation
1 secondary outcome
Suturing time of myoma bed
Time frame: During myomectomy operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 18619922Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
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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.
Mohamed Zayed, M.D,PhD study chair
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Usama M Fouda, M.D,PhD study director
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Khaled A Elsetohy, M.D,PhD 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 myomectomy using barbed sutures and myomectomy using conventional sutures in people with Fibroid, 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 9 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: finished, as of the sponsor's last update on 13 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operative time (time frame: During myomectomy 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 NCT02166411, 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 13 Mar 2020.