Uterine Myoma
Conditions
Brief summary
The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.
Detailed description
The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.
Interventions
PROCEDURESingle-port laparoscopic myomectomy
The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).
PROCEDUREMulti-port laparoscopic myomectomy
The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).
Sponsors
CHA University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 55 years * Image-confirmed uterine myoma * Number of myoma ≤2 and largest size ≤10cm * Women who were scheduled to have laparoscopic myomectomy * Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Exclusion criteria
* Women with pedunculated subserosal myoma or submucosal myoma * Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis * Women with any suggestion of malignant uterine or adnexal diseases * Women with diabetics, malignancy, or malnutrition, which can affect wound healing * Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance * Women who refuse to participate or give consent to the procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suturing time | Intra-operative | the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic satisfaction | Post-surgery 1 month and 3 month | We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire). |
Countries
South Korea
Outcome results
None listed