Uterine MyomaIEMENCT02086435
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
A study testing Extracorporeal morcellation and Intracorporeal morcellation in people with Uterine Myoma, run by University Magna Graecia at 1 site in Italy.
Trial summary
The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Myoma
- What is being tested?
- Extracorporeal morcellation and Intracorporeal morcellation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Apr 2015
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications
- Presence of at least one uterine myoma larger than 4 cm
- Aged between 18 and 40 years
Who cannot join
- Presence of uterine neoformations suspicious for malignancy
- Medical major disorders associated
- Acute or chronic psychiatric disorders
- Ascertained Premenstrual syndrome
- Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
- Presence of calcified fibroids ultrasound examination
Show all 11Show fewer
- Presence of adnexal lesions
- Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding
- Abnormal PAP test
- Positive Pregnancy Test
- Previous use of laparoscopic surgery increased
Trial locations and contacts
1 site in 1 country.
Italy1 site
Chair of Obstetrics and Gynecology - University division - UMG
Catanzaro, CZ, 88100
About this study
Official title: A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.
- Conditions
- Uterine Myoma
- Being tested
- Extracorporeal morcellation, Intracorporeal morcellation
- Keywords
- Myomectomy, Laparoscopic myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal morcellationProcedure or surgery
Also called protected morcellation, morcellation in endobag
patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself
Intracorporeal morcellationProcedure or surgery
Also called Power morcellation, Standard intracorporeal morcellation
patients treated with standard intracorporeal morcellation, using reusable electronic device
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal morcellation | Experimental | Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself Receives: Procedure: Extracorporeal morcellation |
| Intracorporeal morcellation | Active comparator | Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device Receives: Procedure: Intracorporeal morcellation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field
Measured: The day of surgery
Secondary outcomes (6)
Total operative time
from skin incision to skin closure
Measured: The day of surgery
Handling of morcellation
expressed on the VAS scale where 1 means very bad handling and 10 excellent handling
Measured: The day of surgery
Blood loss
Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery
Measured: 2 hours after the end of surgery
Postoperative hospital stay
Measured: The day of patient discharge, average 4 day after surgery
Postoperative pain
measured on the VAS scale where 1 stands for a little pain and 10 for intense pain
Measured: The day of patient discharge, average 4 day after surgery
Rate of complications
need of transfusion or laparotomic conversion
Measured: The day of patient discharge, average 4 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulvio Zullo, University Magna Graecia
- Investigators
- Fulvio Zullo, Principal investigator, Magna Graecia University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086435
- Sponsor's protocol ID
- SafeMorcellation
- Acronym
- IEME
- Status last verified
- Apr 2015
- First submitted
- 9 Mar 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
PubMed 26801067
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
- ClinicalTrials.gov ID
- NCT02086435
- Acronym / sponsor ID
- IEME / SafeMorcellation
- Conditions
- Uterine Myoma
- Keywords
- Myomectomy, Laparoscopic myomectomy, Morcellation, Risk of dissemination, Uterine Sarcoma, Parasitic myoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- 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.
The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal morcellation | Experimental | Procedure: Extracorporeal morcellationExtracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself |
| Intracorporeal morcellation | Active comparator | Procedure: Intracorporeal morcellationIntracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications
- Presence of at least one uterine myoma larger than 4 cm
- Aged between 18 and 40 years
Key exclusion criteria (11 listed)
- Presence of uterine neoformations suspicious for malignancy
- Medical major disorders associated
- Acute or chronic psychiatric disorders
- Ascertained Premenstrual syndrome
- Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
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 |
|---|---|---|
| Extracorporeal morcellationAlso: protected morcellation, morcellation in endobagpatients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself | Procedure or surgery | Extracorporeal morcellation |
| Intracorporeal morcellationAlso: Power morcellation, Standard intracorporeal morcellationpatients treated with standard intracorporeal morcellation, using reusable electronic device | Procedure or surgery | Intracorporeal morcellation |
Primary outcome
Operative time
Time frame: The day of surgery
calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field
6 secondary outcomes
Total operative time
Time frame: The day of surgery
Handling of morcellation
Time frame: The day of surgery
Blood loss
Time frame: 2 hours after the end of surgery
Postoperative hospital stay
Time frame: The day of patient discharge, average 4 day after surgery
Postoperative pain
Time frame: The day of patient discharge, average 4 day after surgery
Rate of complications
Time frame: The day of patient discharge, average 4 day after surgery
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 21 Apr 2015.
- Derived from this study: PubMed 26801067Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
Related trials for Uterine Myoma
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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.
Fulvio Zullo principal investigator
Magna Graecia University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal morcellation and Intracorporeal morcellation in people with Uterine Myoma, run by University Magna Graecia at 1 site in Italy.
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 3 inclusion and 11 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 21 Apr 2015. 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 Italy. 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. 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?
Operative time (time frame: The day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086435, which also lists 1 linked publication.
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 21 Apr 2015.