- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01984632
Barbed Suture in Single-port Laparoscopic Myomectomy
July 30, 2015 updated by: Taejong Song, CHA University
Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Goyang, Korea, Republic of
- National Health Insurance Service Ilsan Hospital
-
Seoul, Korea, Republic of
- Samsung Medical Center
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Seoul, Korea, Republic of
- CHA Gangnam Medical Center
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Seoul, Korea, Republic of
- Kangbuk Samsung Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-port laparoscopic myomectomy
We will use barbed suture (V-Loc) under intervention of single-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).
|
Active Comparator: Multi-port laparoscopic myomectomy
We will use barbed suture(V-Loc) under intervention of multi-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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suturing time
Time Frame: Intra-operative
|
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy
|
Intra-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmetic satisfaction
Time Frame: Post-surgery 1 month and 3 month
|
We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).
|
Post-surgery 1 month and 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
November 3, 2013
First Submitted That Met QC Criteria
November 14, 2013
First Posted (Estimate)
November 15, 2013
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MYO04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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