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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05804617
Collaborator
(none)
41
1
2
27.4
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Dome-type (Modified C-incision) manual morcellation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis
Actual Study Start Date :
May 20, 2020
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Surgeon group

Dome-type morcellation performed by one skillful surgeon

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

Active Comparator: Trainee group

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

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

Outcome Measures

Primary Outcome Measures

  1. Morcellation speed [During procedure]

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

Secondary Outcome Measures

  1. Age [Before procedure]

    Age

  2. BMI (kg/m2) [Before procedure]

    BMI

  3. Abdominal surgical history [Before procedure]

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

  4. Stiffness [During procedure]

    Categorize to soft or hard

  5. Umbilical wound size (cm) [During procedure]

    Umbilical wound size

  6. Pathology [1 week (after the pathologic report being released)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women at any age undergoing laparoscopic surgeries with dome-type morcellation
Exclusion Criteria:
  • Women with extremely huge specimen (>2000 gm)

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chi-Hau Chen, PhD, Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05804617
Other Study ID Numbers:
  • 202206083RINB
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 7, 2023