Surgical Procedure, UnspecifiedNCT05804617
Dome-type (Modified C-incision) Manual Morcellation During Laparoscopic Uterine Surgery
A study testing Dome-type (Modified C-incision) manual morcellation in people with Surgical Procedure, Unspecified, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Dome-type (Modified C-incision) manual morcellation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women at any age undergoing laparoscopic surgeries with dome-type morcellation
Who cannot join
- Women with extremely huge specimen (>2000 gm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis
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.
Read the 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
- Being tested
- Dome-type (Modified C-incision) manual morcellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dome-type (Modified C-incision) manual morcellationProcedure or surgery
Morcellation performed by surgeon or trainee
| Study group | Role | What they receive |
|---|---|---|
| Surgeon group | Placebo comparator | Dome-type morcellation performed by one skillful surgeon Receives: Procedure: Dome-type (Modified C-incision) manual morcellation |
| Trainee group | Active comparator | Dome-type morcellation performed by trainees (residents) under supervision Receives: Procedure: Dome-type (Modified C-incision) manual morcellation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morcellation speed
Weight of specimen (gram) divided by morcellation time (minute)
Measured: During procedure
Secondary outcomes (6)
Age
Age
Measured: Before procedure
BMI (kg/m2)
BMI
Measured: Before procedure
Abdominal surgical history
Any abdominal surgical history, e.g., Cesarean section, myomectomy, appendectomy...
Measured: Before procedure
Stiffness
Categorize to soft or hard
Measured: During procedure
Umbilical wound size (cm)
Umbilical wound size
Measured: During procedure
Pathology
Final pathologic result, e.g., leiomyoma, adenomyosis...
Measured: 1 week (after the pathologic report being released)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start20 May 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Hau Chen, PhD, Principal investigator, Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804617
- Sponsor's protocol ID
- 202206083RINB
- Status last verified
- Sep 2022
- First submitted
- 20 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dome-type (Modified C-incision) Extracorporeal Manual Morcellation During Laparoscopic Uterine Surgery: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05804617
- Acronym / sponsor ID
- 202206083RINB
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon group | Placebo comparator | Procedure: Dome-type (Modified C-incision) manual morcellationDome-type morcellation performed by one skillful surgeon |
| Trainee group | Active comparator | Procedure: Dome-type (Modified C-incision) manual morcellationDome-type morcellation performed by trainees (residents) under supervision |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at any age undergoing laparoscopic surgeries with dome-type morcellation
Key exclusion criteria (1 listed)
- Women with extremely huge specimen (>2000 gm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dome-type (Modified C-incision) manual morcellationMorcellation performed by surgeon or trainee | Procedure or surgery | Surgeon group, Trainee group |
Primary outcome
Morcellation speed
Time frame: During procedure
Weight of specimen (gram) divided by morcellation time (minute)
6 secondary outcomes
Age
Time frame: Before procedure
BMI (kg/m2)
Time frame: Before procedure
Abdominal surgical history
Time frame: Before procedure
Stiffness
Time frame: During procedure
Umbilical wound size (cm)
Time frame: During procedure
Pathology
Time frame: 1 week (after the pathologic report being released)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Hau Chen, PhD principal investigator
Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dome-type (Modified C-incision) manual morcellation in people with Surgical Procedure, Unspecified, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morcellation speed (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.