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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804617
• Other study ID #: 202206083RINB
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with extremely huge specimen (>2000 gm)

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Procedure:
• Dome-type (Modified C-incision) manual morcellation
Morcellation performed by surgeon or trainee

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morcellation speed	Weight of specimen (gram) divided by morcellation time (minute)	During procedure
Secondary	Age	Age	Before procedure
Secondary	BMI (kg/m2)	BMI	Before procedure
Secondary	Abdominal surgical history	Any abdominal surgical history, e.g., Cesarean section, myomectomy, appendectomy...	Before procedure
Secondary	Stiffness	Categorize to soft or hard	During procedure
Secondary	Umbilical wound size (cm)	Umbilical wound size	During procedure
Secondary	Pathology	Final pathologic result, e.g., leiomyoma, adenomyosis...	1 week (after the pathologic report being released)