An interventional study of Dome-type (Modified C-incision) manual morcellation in Surgical Procedure, Unspecified, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported. Therefore, we developed a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.
Background: In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported.
Objective: To describe using a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.
Study Design: Retrospective review of consecutive laparoscopic myomectomies or hysterectomies performed between May 2020 and September 2022 in which the specimen was manually morcellated using the dome-type technique by surgeon or trainees.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dome-type morcellation performed by one skillful surgeon
Procedure: Dome-type (Modified C-incision) manual morcellation
Dome-type morcellation performed by trainees (residents) under supervision
Procedure: Dome-type (Modified C-incision) manual morcellation
Morcellation performed by surgeon or trainee
Morcellation speed
Weight of specimen (gram) divided by morcellation time (minute)
Time frame: During procedure
Age
Age
Time frame: Before procedure
BMI (kg/m2)
BMI
Time frame: Before procedure
Abdominal surgical history
Any abdominal surgical history, e.g., Cesarean section, myomectomy, appendectomy...
Time frame: Before procedure
Stiffness
Categorize to soft or hard
Time frame: During procedure
Umbilical wound size (cm)
Umbilical wound size
Time frame: During procedure
Pathology
Final pathologic result, e.g., leiomyoma, adenomyosis...
Time frame: 1 week (after the pathologic report being released)
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital