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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Procedure: Dome-type (Modified C-incision) manual morcellation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women at any age undergoing laparoscopic surgeries with dome-type morcellation Exclusion Criteria: Women with extremely huge specimen (>2000 gm)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |