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Completed

NCT Number: NCT05804617

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

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.

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Key information

Conditions

Surgical Procedure, Unspecified

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women with extremely huge specimen (>2000 gm)

Treatment and study plan

Dome-type (Modified C-incision) manual morcellation

Procedure

Morcellation performed by surgeon or trainee

Primary outcomes

  1. Morcellation speed

    Time frame: During procedure

    Weight of specimen (gram) divided by morcellation time (minute)

Secondary outcomes

  1. Age

    Time frame: Before procedure

    Age

  2. BMI (kg/m2)

    Time frame: Before procedure

    BMI

  3. Abdominal surgical history

    Time frame: Before procedure

    Any abdominal surgical history, e.g., Cesarean section, myomectomy, appendectomy...

  4. Stiffness

    Time frame: During procedure

    Categorize to soft or hard

  5. Umbilical wound size (cm)

    Time frame: During procedure

    Umbilical wound size

  6. Pathology

    Time frame: 1 week (after the pathologic report being released)

    Final pathologic result, e.g., leiomyoma, adenomyosis...

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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