Laparoscopic Hysterectomy
Conditions
Brief summary
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
Interventions
DEVICEMONOFIX® PGCL
An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.
DEVICEQuill Monoderm™
An absorbable suture made of polyglactin used for soft tissue suture.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Patients scheduled for hysterectomy by laparoscopic surgery * Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator * Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)
Exclusion criteria
1. Patients with contaminated wounds 2. Diseases that may affect wound healing 3. When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time used for suturing the surgical site during laparoscopic hysterectomy | 0Day | Time used from when the first suture is started to when the last suture is finished and the suture is cut |
Countries
South Korea
Contacts
Primary ContactMiryung Jin
Outcome results
None listed