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

Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Dome-type (Modified C-incision) manual morcellation

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Women with extremely huge specimen (>2000 gm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Surgeon group; Dome-type morcellation performed by one skillful surgeon	Procedure: Dome-type (Modified C-incision) manual morcellation; Morcellation performed by surgeon or trainee
Active Comparator: Trainee group; Dome-type morcellation performed by trainees (residents) under supervision	Procedure: Dome-type (Modified C-incision) manual morcellation; Morcellation performed by surgeon or trainee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morcellation speed	Weight of specimen (gram) divided by morcellation time (minute)	During procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chi-Hau Chen, PhD, Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202206083RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No