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

NCT ID: NCT05804617

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2022-09-01

Brief 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.

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.

Conditions

Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surgeon group

Dome-type morcellation performed by one skillful surgeon

Group Type: PLACEBO_COMPARATOR

Dome-type (Modified C-incision) manual morcellation

Intervention Type: PROCEDURE

Morcellation performed by surgeon or trainee

Trainee group

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

Group Type: ACTIVE_COMPARATOR

Dome-type (Modified C-incision) manual morcellation

Intervention Type: PROCEDURE

Morcellation performed by surgeon or trainee

Interventions

Dome-type (Modified C-incision) manual morcellation

Morcellation performed by surgeon or trainee

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Women with extremely huge specimen (>2000 gm)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi-Hau Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202206083RINB

Identifier Type: -

Identifier Source: org_study_id