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

National Taiwan University

Status: Completed

Conditions: Surgical Procedure, Unspecified

Treatments: Procedure: Dome-type (Modified C-incision) manual morcellation

Study type: Interventional

Funder types: Other

Identifiers

NCT05804617

202206083RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Women with extremely huge specimen (>2000 gm)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

Surgeon group

Placebo Comparator group

Description:

Dome-type morcellation performed by one skillful surgeon

Treatment:

Procedure: Dome-type (Modified C-incision) manual morcellation

Trainee group

Active Comparator group

Description:

Dome-type morcellation performed by trainees (residents) under supervision

Treatment:

Procedure: Dome-type (Modified C-incision) manual morcellation