Laparoscopic Myomectomy Using Barbed or Conventional Sutures
Primary Purpose
Fibroid
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
myomectomy using barbed sutures
myomectomy using conventional sutures
Sponsored by
About this trial
This is an interventional treatment trial for Fibroid focused on measuring Myomectomy ,Laparoscopy , Barbed sutures
Eligibility Criteria
Inclusion Criteria:
- the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
Exclusion Criteria:
- submucosal myoma
- calcified myomas
- uterine size more than 16 weeks
- suspension of genital malignancy
- coagulation defects or concurrent anticoagulant therapy
- pregnancy
- compromised cardiopulmonary status
- previous treatment with gonadotropin-releasing hormone analogue
- contraindications for general anesthesia.
Sites / Locations
- Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
myomectomy using barbed sutures
myomectomy using conventional sutures
Arm Description
.Myoma bed is sutured with barbed sutures
Myoma bed is sutured with conventional sutures
Outcomes
Primary Outcome Measures
Operative time
Secondary Outcome Measures
Suturing time of myoma bed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02166411
Brief Title
Laparoscopic Myomectomy Using Barbed or Conventional Sutures
Official Title
Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 .
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid
Keywords
Myomectomy ,Laparoscopy , Barbed sutures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
myomectomy using barbed sutures
Arm Type
Experimental
Arm Description
.Myoma bed is sutured with barbed sutures
Arm Title
myomectomy using conventional sutures
Arm Type
Active Comparator
Arm Description
Myoma bed is sutured with conventional sutures
Intervention Type
Procedure
Intervention Name(s)
myomectomy using barbed sutures
Intervention Description
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 ).
Intervention Type
Procedure
Intervention Name(s)
myomectomy using conventional sutures
Intervention Description
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)
Primary Outcome Measure Information:
Title
Operative time
Time Frame
During myomectomy operation
Secondary Outcome Measure Information:
Title
Suturing time of myoma bed
Time Frame
During myomectomy operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
Exclusion Criteria:
submucosal myoma
calcified myomas
uterine size more than 16 weeks
suspension of genital malignancy
coagulation defects or concurrent anticoagulant therapy
pregnancy
compromised cardiopulmonary status
previous treatment with gonadotropin-releasing hormone analogue
contraindications for general anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Zayed, M.D,PhD
Organizational Affiliation
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, M.D,PhD
Organizational Affiliation
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled A Elsetohy, M.D,PhD
Organizational Affiliation
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
18619922
Citation
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.
Results Reference
background
Learn more about this trial
Laparoscopic Myomectomy Using Barbed or Conventional Sutures
We'll reach out to this number within 24 hrs