FibroidsNCT01347385
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy
A study testing Laparoscopic myomectomy with unidirectional barbed suture and Traditional suture material in people with Fibroids, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fibroids
- What is being tested?
- Laparoscopic myomectomy with unidirectional barbed suture and Traditional suture material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women who are planning to undergo laparoscopic myomectomy
Who cannot join
- greater than five fibroids
- uterus extending beyond the umbilicus
- major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- patients undergoing concomitant surgical procedures at the time of myomectomy (such as resection of endometriosis or ovarian cystectomy)
- pregnancy (all patients will have serum pregnancy testing prior to surgery)
- patients with any suggestion of abnormal pathology on imaging or endometrial biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial
The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.
Read the detailed description
Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.
- Conditions
- Fibroids
- Being tested
- Laparoscopic myomectomy with unidirectional barbed suture, Traditional suture material
- Keywords
- Fibroids, Laparoscopic myomectomy, Barbed suture
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic myomectomy with unidirectional barbed sutureProcedure or surgery
Also called V-Loc 180TM, CovidienTM
Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.
Traditional suture materialProcedure or surgery
Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.
| Study group | Role | What they receive |
|---|---|---|
| Barbed suture | Experimental | Not described Receives: Procedure: Laparoscopic myomectomy with unidirectional barbed suture |
| Traditional suture material | Active comparator | Not described Receives: Procedure: Traditional suture material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.
Secondary outcomes (4)
Blood loss
We will subtract the amount of irrigation fluid used from the total amount of fluid suctioned during the procedure to arrive at an estimated blood loss in millilitres. We will also measure the patient's hemoglobin at the routine pre-operative visit and then on the morning of the first post-operative day to determine the difference in hemoglobin. The amount of intravenous fluids administered to the patients intra- and post-operatively will be documented in order to account for any changes in hemoglobin that are spurious due to fluid administration.
Measured: Intra-operative
Adverse events
All adverse events that occur until 6 weeks post-operatively will be documented including injury to the bladder, bowel, ureter or blood vessel, infection/abscess, fever, blood transfusion, readmission to hospital, re-operation, and venous thromboembolism.
Measured: Intra-operatively until 6 weeks post-operatively
Hospital stay
We will document the length of hospital stay post-operatively in days.
Fertility and pregnancy-related outcomes
Telephone interviews will be conducted at 2 and 5 years post-operatively to determine pregnancy rates, live birth rates and adverse pregnancy outcomes of participants.
Measured: 2 and 5 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Jamie Kroft, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences Centre, University of TorontoGrace Y Liu, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347385
- Sponsor's protocol ID
- MIS-1
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01347385
- Acronym / sponsor ID
- MIS-1
- Conditions
- Fibroids
- Keywords
- Fibroids, Laparoscopic myomectomy, Barbed suture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- First posted
- 4 May 2011 (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 objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.
Detailed description
Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barbed suture | Experimental | Procedure: Laparoscopic myomectomy with unidirectional barbed suture |
| Traditional suture material | Active comparator | Procedure: Traditional suture material |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women who are planning to undergo laparoscopic myomectomy
Key exclusion criteria (6 listed)
- greater than five fibroids
- uterus extending beyond the umbilicus
- major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- patients undergoing concomitant surgical procedures at the time of myomectomy (such as resection of endometriosis or ovarian cystectomy)
- pregnancy (all patients will have serum pregnancy testing prior to surgery)
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 |
|---|---|---|
| Laparoscopic myomectomy with unidirectional barbed sutureAlso: V-Loc 180TM, CovidienTMPatients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer. | Procedure or surgery | Barbed suture |
| Traditional suture materialPatients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material. | Procedure or surgery | Traditional suture material |
Primary outcome
Operative time
We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.
4 secondary outcomes
Blood loss
Time frame: Intra-operative
Adverse events
Time frame: Intra-operatively until 6 weeks post-operatively
Hospital stay
Fertility and pregnancy-related outcomes
Time frame: 2 and 5 years post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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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.
Jamie Kroft, MD, FRCSC principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
Grace Y Liu, MD, FRCSC principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic myomectomy with unidirectional barbed suture and Traditional suture material in people with Fibroids, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 4 May 2011. 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 Canada. 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?
Contact Jamie Kroft, MD, FRCSC (416-480-6100 ext. 5063, jamie.kroft@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2011.