Dome-type (Modified C-incision) Manual Morcellation During Laparoscopic Uterine Surgery

Not Applicable

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Procedure: Dome-type (Modified C-incision) manual morcellation

• Registration Number: NCT05804617
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2020-05-20
• Status Verified: 2022-09
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

• Women with extremely huge specimen (>2000 gm)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgeon group	Dome-type (Modified C-incision) manual morcellation	Dome-type morcellation performed by one skillful surgeon
Trainee group	Dome-type (Modified C-incision) manual morcellation	Dome-type morcellation performed by trainees (residents) under supervision

Primary Outcome Measures

Name	Time	Method
Morcellation speed	During procedure	Weight of specimen (gram) divided by morcellation time (minute)

Secondary Outcome Measures

Name	Time	Method
Umbilical wound size (cm)	During procedure	Umbilical wound size
Age	Before procedure	Age
Abdominal surgical history	Before procedure	Any abdominal surgical history, e.g., Cesarean section, myomectomy, appendectomy...
BMI (kg/m2)	Before procedure	BMI
Stiffness	During procedure	Categorize to soft or hard
Pathology	1 week (after the pathologic report being released)	Final pathologic result, e.g., leiomyoma, adenomyosis...

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan