Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
Sponsor:
First Peoples Hospital of Hangzhou
Organization:
First Peoples Hospital of Hangzhou
Study Overview
Official Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal
Research Design This study is a single-center randomized single-blind 11 controlled trial
Intervention Measures Study participants were randomly assigned in a 11 ratio into two groups
Experimental group Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids
Control group Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids
Observation Indicators Primary observation indicator Time required for fibroid fragmentation and retrieval from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity
Secondary observation indicators Success rate of placement intraoperative damage and leakage rate gynecological surgeon satisfaction with the surgery total weight of retrieved uterine fibroid fragments
Research Design This study is a single-center randomized single-blind 11 controlled trial
Intervention Measures Study participants were randomly assigned in a 11 ratio into two groups
Experimental group Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids
Control group Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids
Observation Indicators Primary observation indicator Time required for fibroid fragmentation and retrieval from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity
Secondary observation indicators Success rate of placement intraoperative damage and leakage rate gynecological surgeon satisfaction with the surgery total weight of retrieved uterine fibroid fragments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None