Uterine MyomasPhase 4NCT00743080
Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators
A Phase 4 study testing Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX and Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1 in people with Uterine Myomas, run by University Magna Graecia at 1 site in Italy.
Trial summary
To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular electronic power morcellators have become instruments of large use in surgical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Myomas
- What is being tested?
- Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX and Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Jan 2010
- Phase
- Phase 4
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic uterine leiomyomas with main diameter over 5 cm
Who cannot join
- Major medical conditions
- Endocrinologic diseases
- Current or past, acute or chronic psychiatric disorders
- Premenstrual syndrome
- Use of drugs influencing cognition, vigilance and/or mood within six months of the study enrolment
- Hypoechoic or calcified leiomyomas at ultrasound
Show all 10Show fewer
- Associated lesions in the uterus and adnexa at ultrasound
- Pattern of hyperplasia with cytologic atypia in the endometrial biopsy
- Abnormal Papanicolau smear test
- Positive urine pregnancy test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study
To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular electronic power morcellators have become instruments of large use in surgical practice.
The tissue morcellator is an endoscopic instrument indicated for cutting, coring and extracting tissue in operative laparoscopy, and it has a pivotal role during specific gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered by electronic morcellator consist in reduction of operative time and of risk in hernia formation, this last due to the absence of fascia's tearing or stretching.
Read more
Recently, a new generation of tissue morcellator has been commercialized. In particular, GYNECARE MORCELLEX (Ethicon-Johnson \& Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver City, CA, US) are two tissue morcellators currently available. These instruments seem to offer advantages over the previous models in terms of precision, speed and durability. The most useful of this features seems to be the higher speed, in particular it has been calculated that they morcellate tissues approximately four times faster than those of the previous generation. The high speed that characterizes this new morcellator potentially results in reduced operative time with consequent benefits in other surgical outcomes such as postoperative pain and recovery time.
Even if both morcellator seems to be high-quality instruments, no study was designed until now to compare these two tools in a prospective fashion.
Read the detailed description
Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be enrolled in the present protocol-study.
At entry, in each woman age, parity, body mass index (BMI), menopausal, socioeconomic and work status, symptoms related to the gynecologic disease, previous major surgical laparotomies, and associated medical condition will be assessed.
All eligible patients will be randomized in single blocks using a central computer generating randomization lists (University of Catanzaro). The subjects will be assigned to one of four subgroups of surgical treatment, i.e. group A1 myomectomies performed using GYNECARE MORCELLEX, group A2 supracervical hysterectomies performed using GYNECARE MORCELLEX, group B1 myomectomies performed using ROTOCUT G1 and group B2 supracervical hysterectomies performed using ROTOCUT G1.
Before surgery, for each patient gynaecological and rectal examination, Papanicolau smear test, ultrasonographic and hysteroscopic assessment with endometrial biopsy will be performed.
For each surgical intervention the following parameters will be recorded: duration of surgical procedures, intra-operative blood loss, amount of blood transfusion, intra-operative complications, number of laparotomic conversion, postoperative pain, post-operative complications, hospital stay, and time to return to full activity and/or work.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
- Conditions
- Uterine Myomas
- Being tested
- Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX, Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1
- Keywords
- laparoscopy, myomectomy, myomas, morcellator, supracervical hysterectomy, surgery, symptomatic uterine myomas
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEXProcedure or surgery
Laparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX).
Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation.
Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1Procedure or surgery
Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1).
Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic myomectomy and supracervical hysterectomy using GYNECARE MORCELLEX Receives: Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX |
| 2 | Active comparator | Laparoscopic myomectomy and supracervical hysterectomy using ROTOCUT G1 Receives: Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morcellament time
Secondary outcomes (7)
Total operative time
Feasibility [subjective score of difficulty]
Blood loss
Post-operative complications
Measured: 12 months
Postoperative pain
Hospital stay
Time to return to full activity and/or work
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJan 2008
- Study completionJan 2010
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 MyomasStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Fulvio Zullo, MD, PhD, Principal investigator, Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, - Viale Europa Loc. Germaneto 88100 Catanzaro, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743080
- Sponsor's protocol ID
- 300-07-015
- Status last verified
- Aug 2008
- First submitted
- 26 Aug 2008
- Last updated
- 3 Nov 2010
- Results posted
- No
Publications
Zullo F, Falbo A, Iuliano A, Oppedisano R, Sacchinelli A, Annunziata G, Venturella R, Materazzo C, Tolino A, Palomba S. Randomized controlled study comparing the Gynecare Morcellex and Rotocut G1 tissue morcellators. J Minim Invasive Gynecol. 2010 Mar-Apr;17(2):192-9. doi: 10.1016/j.jmig.2009.11.009.
PubMed 20226407
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00743080
- Acronym / sponsor ID
- 300-07-015
- Conditions
- Uterine Myomas
- Keywords
- laparoscopy, myomectomy, myomas, morcellator, supracervical hysterectomy, surgery, symptomatic uterine myomas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2008
- Study completion
- Jan 2010
- First posted
- 28 Aug 2008 (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.
To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular electronic power morcellators have become instruments of large use in surgical practice.
The tissue morcellator is an endoscopic instrument indicated for cutting, coring and extracting tissue in operative laparoscopy, and it has a pivotal role during specific gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered by electronic morcellator consist in reduction of operative time and of risk in hernia formation, this last due to the absence of fascia's tearing or stretching.
Recently, a new generation of tissue morcellator has been commercialized. In particular, GYNECARE MORCELLEX (Ethicon-Johnson \& Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver City, CA, US) are two tissue morcellators currently available. These instruments seem to offer advantages over the previous models in terms of precision, speed and durability. The most useful of this features seems to be the higher speed, in particular it has been calculated that they morcellate tissues approximately four times faster than those of the previous generation. The high speed that characterizes this new morcellator potentially results in reduced operative time with consequent benefits in other surgical outcomes such as postoperative pain and recovery time.
Even if both morcellator seems to be high-quality instruments, no study was designed until now to compare these two tools in a prospective fashion.
Detailed description
Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be enrolled in the present protocol-study.
At entry, in each woman age, parity, body mass index (BMI), menopausal, socioeconomic and work status, symptoms related to the gynecologic disease, previous major surgical laparotomies, and associated medical condition will be assessed.
All eligible patients will be randomized in single blocks using a central computer generating randomization lists (University of Catanzaro). The subjects will be assigned to one of four subgroups of surgical treatment, i.e. group A1 myomectomies performed using GYNECARE MORCELLEX, group A2 supracervical hysterectomies performed using GYNECARE MORCELLEX, group B1 myomectomies performed using ROTOCUT G1 and group B2 supracervical hysterectomies performed using ROTOCUT G1.
Before surgery, for each patient gynaecological and rectal examination, Papanicolau smear test, ultrasonographic and hysteroscopic assessment with endometrial biopsy will be performed.
For each surgical intervention the following parameters will be recorded: duration of surgical procedures, intra-operative blood loss, amount of blood transfusion, intra-operative complications, number of laparotomic conversion, postoperative pain, post-operative complications, hospital stay, and time to return to full activity and/or work.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEXLaparoscopic myomectomy and supracervical hysterectomy using GYNECARE MORCELLEX |
| 2 | Active comparator | Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1Laparoscopic myomectomy and supracervical hysterectomy using ROTOCUT G1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic uterine leiomyomas with main diameter over 5 cm
Key exclusion criteria (10 listed)
- Major medical conditions
- Endocrinologic diseases
- Current or past, acute or chronic psychiatric disorders
- Premenstrual syndrome
- Use of drugs influencing cognition, vigilance and/or mood within six months of the study enrolment
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 |
|---|---|---|
| Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEXLaparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX). Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation. | Procedure or surgery | 1 |
| Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1). Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation. | Procedure or surgery | 2 |
Primary outcome
Morcellament time
7 secondary outcomes
Total operative time
Feasibility [subjective score of difficulty]
Blood loss
Post-operative complications
Time frame: 12 months
Postoperative pain
Hospital stay
Time to return to full activity and/or work
Time frame: 12 months
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 3 Nov 2010.
- Results publication: PubMed 20226407Zullo F, Falbo A, Iuliano A, Oppedisano R, Sacchinelli A, Annunziata G, Venturella R, Materazzo C, Tolino A, Palomba S. Randomized controlled study comparing the Gynecare Morcellex and Rotocut G1 tissue morcellators. J Minim Invasive Gynecol. 2010 Mar-Apr;17(2):192-9. doi: 10.1016/j.jmig.2009.11.009.
Related trials for Uterine Myomas
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 4
Prescription of Letrozole for Uterine Myoma
Leiomyoma, Uterine, Leiomyoma
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
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, MD, PhD principal investigator
Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, - Viale Europa Loc. Germaneto 88100 Catanzaro, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX and Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1 in people with Uterine Myomas, 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 1 inclusion and 10 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 3 Nov 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Morcellament time. 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 NCT00743080, 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 3 Nov 2010.