Clinical trial NCT05804617: Dome-type (Modified C-incision) Manual Morcellation During Laparoscopic Uterine Surgery
Official title: Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women at any age undergoing laparoscopic surgeries with dome-type morcellation

Exclusion Criteria:

* Women with extremely huge specimen (\>2000 gm)

Primary outcomes:
measure: Morcellation speed
timeFrame: During procedure
Secondary outcomes:
measure: Age
timeFrame: Before procedure
measure: BMI (kg/m2)
timeFrame: Before procedure
measure: Abdominal surgical history
timeFrame: Before procedure
measure: Stiffness
timeFrame: During procedure
measure: Umbilical wound size (cm)
timeFrame: During procedure
measure: Pathology
timeFrame: 1 week (after the pathologic report being released)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan
name: Chi-Hau Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: