NCT05804617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

February 20, 2023

Last Update Submit

March 27, 2023

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Morcellation speed

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

    During procedure

Secondary Outcomes (6)

  • Age

    Before procedure

  • BMI (kg/m2)

    Before procedure

  • Abdominal surgical history

    Before procedure

  • Stiffness

    During procedure

  • Umbilical wound size (cm)

    During procedure

  • +1 more secondary outcomes

Study Arms (2)

Surgeon group

PLACEBO COMPARATOR

Dome-type morcellation performed by one skillful surgeon

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

Trainee group

ACTIVE COMPARATOR

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

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

Interventions

Dome-type (Modified C-incision) manual morcellationPROCEDURE

Morcellation performed by surgeon or trainee

Surgeon groupTrainee group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women with extremely huge specimen (\>2000 gm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Chi-Hau Chen, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

April 7, 2023

Study Start

May 20, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 7, 2023

Record last verified: 2022-09

Locations

TW(1)