Uterine MyomaNCT04279626
Surgical Outcome of Two-port Laparoscopic Myomectomy
An observational study of Uterine Myoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees. Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Uterine Myoma
- What is being tested?
- LETS-M
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2015to 23 Sep 2019
- Phase
- Observational
- 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 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency and constipation, received LETS-M for their uterine myoma.
Who may be able to join
- Women older than 20 years old and had not reached menopause
- Symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation.
Who cannot join
- Dominant symptoms with active pelvic or urinary tract infection
- A history of pelvic radiotherapy
- A preexisting or suspicious malignant pelvic tumor
- Pathologies other than uterine myoma noted during the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Surgical Outcome of Two-port Laparoscopic Myomectomy Using Conventional Laparoscopic Instruments and Glove-port Technique
Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees.
Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M
Read the detailed description
Laparoscopic myomectomy (LM) is an alternative and advanced technique that can take the place of traditional open surgery and achieve the goal of minimally invasive operation for women who wish to preserve the uterus. However, LM is considered a time-consuming procedure, requiring more suturing and knot-tying, and is better performed for woman with an appropriate uterine size by experienced surgeons.
Laparoendoscopic two-sites myomectomy (LETS-M) is a novel setting for LM on a two-port basis, using the umbilical glove port, three trocars, and conventional laparoscopic equipment.
Between January 2015 and September 2019, the medical records of women with uterine myoma managed by LETS-M were retrospectively reviewed.
The review of the chart records consisted of a detailed history, such as age, body mass index (BMI), gravidity, parity, marital status, sexual experience, previous abdominal surgery, and hospital stay after the surgery. All women received preoperative ultrasound for their uterine myoma assessment, including the location, type, size, number, and accompanying pathology, such as an ovarian tumor. The myoma locations were identified during the operation and classified into fundal wall myoma, anterior wall myoma, posterior wall myoma, and cervical myoma. The myoma type classification was based on the International Federation of Gynecology and Obstetrics (FIGO) leiomyoma subclassification system. We measured the weight of the specimen after finishing the surgery. The operation time was defined as the period from the incision to the closure of the skin. Any intraoperative blood loss less than 50mL or minimal blood loss on operation note was recorded as 50 milliliters in this study. Excessive blood loss was defined as more or equal to 500 milliliters in the operation. The postoperative pain scale was evaluated by a visual analog scale (VAS) on the first and second postoperative days.
- Conditions
- Uterine Myoma
- Being tested
- LETS-M
- Keywords
- Laparoscopy, Two-port
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LETS-MProcedure or surgery
A 1.5-centimeter skin incision was made over the umbilicus, and the abdominal wall was opened layer by layer with an open method. A wound retractor (Alexis, 2-4 centimeter; Applied Medical Resources Corp., Rancho Santa Margarita, CA) was placed, and the glove port was set up, with a 10-millimeter trocar in the thumb over patient's right side, and a 5-millimeter trocar in the little finger over the left side. The pneumoperitoneum was established. A 10-millimeter rigid laparoscope was inserted via the 10-millimeter trocar and controlled by the assistant. The ancillary 5-millimeter port was made over the left lower abdomen under laparoscope inspection. The surgeon performed the surgery via the two 5-millimeter trocars.
| Study group | Role | What they receive |
|---|---|---|
| LETS-M | Women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation, received LETS-M. Receives: Procedure: LETS-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
The operation time was defined as the period from the incision to the closure of the skin.
Measured: 1 day (the operation day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start21 Jan 2015
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Chun Chang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279626
- Sponsor's protocol ID
- 202001027RINA
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Lee D, Lee JR, Suh CS, Kim SH. A systematic review and meta-analysis comparing single port laparoscopic myomectomy with conventional laparoscopic myomectomy. Eur J Obstet Gynecol Reprod Biol. 2019 Aug;239:52-59. doi: 10.1016/j.ejogrb.2019.06.001. Epub 2019 Jun 3.
PubMed 31181399Stewart EA. Uterine fibroids. Lancet. 2001 Jan 27;357(9252):293-8. doi: 10.1016/S0140-6736(00)03622-9.
PubMed 11214143Chang WC, Huang SC, Sheu BC. Advances in gynecological laparoscopic surgery. J Formos Med Assoc. 2010 Apr;109(4):245-7. doi: 10.1016/s0929-6646(10)60049-6. No abstract available.
PubMed 20440899Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):587-92. doi: 10.1016/j.jmig.2010.04.009. Epub 2010 Jun 23.
PubMed 20576473Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
PubMed 21345435Huang PS, Sheu BC, Huang SC, Chang WC. Intraligamental Myomectomy Strategy Using Laparoscopy. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):954-61. doi: 10.1016/j.jmig.2016.06.007. Epub 2016 Jun 18.
PubMed 27327965
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Outcome of Two-port Laparoscopic Myomectomy Using Conventional Laparoscopic Instruments and Glove-port Technique
- ClinicalTrials.gov ID
- NCT04279626
- Acronym / sponsor ID
- 202001027RINA
- Conditions
- Uterine Myoma
- Keywords
- Laparoscopy, Two-port
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 21 Feb 2020 (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.
Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees.
Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M
Detailed description
Laparoscopic myomectomy (LM) is an alternative and advanced technique that can take the place of traditional open surgery and achieve the goal of minimally invasive operation for women who wish to preserve the uterus. However, LM is considered a time-consuming procedure, requiring more suturing and knot-tying, and is better performed for woman with an appropriate uterine size by experienced surgeons.
Laparoendoscopic two-sites myomectomy (LETS-M) is a novel setting for LM on a two-port basis, using the umbilical glove port, three trocars, and conventional laparoscopic equipment.
Between January 2015 and September 2019, the medical records of women with uterine myoma managed by LETS-M were retrospectively reviewed.
The review of the chart records consisted of a detailed history, such as age, body mass index (BMI), gravidity, parity, marital status, sexual experience, previous abdominal surgery, and hospital stay after the surgery. All women received preoperative ultrasound for their uterine myoma assessment, including the location, type, size, number, and accompanying pathology, such as an ovarian tumor. The myoma locations were identified during the operation and classified into fundal wall myoma, anterior wall myoma, posterior wall myoma, and cervical myoma. The myoma type classification was based on the International Federation of Gynecology and Obstetrics (FIGO) leiomyoma subclassification system. We measured the weight of the specimen after finishing the surgery. The operation time was defined as the period from the incision to the closure of the skin. Any intraoperative blood loss less than 50mL or minimal blood loss on operation note was recorded as 50 milliliters in this study. Excessive blood loss was defined as more or equal to 500 milliliters in the operation. The postoperative pain scale was evaluated by a visual analog scale (VAS) on the first and second postoperative days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LETS-M | – | Procedure: LETS-MWomen who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation, received LETS-M. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency and constipation, received LETS-M for their uterine myoma.
Key inclusion criteria (2 listed)
- Women older than 20 years old and had not reached menopause
- Symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation.
Key exclusion criteria (4 listed)
- Dominant symptoms with active pelvic or urinary tract infection
- A history of pelvic radiotherapy
- A preexisting or suspicious malignant pelvic tumor
- Pathologies other than uterine myoma noted during the operation
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 |
|---|---|---|
| LETS-MA 1.5-centimeter skin incision was made over the umbilicus, and the abdominal wall was opened layer by layer with an open method. A wound retractor (Alexis, 2-4 centimeter; Applied Medical Resources Corp., Rancho Santa Margarita, CA) was placed, and the glove port was set up, with a 10-millimeter trocar in the thumb over patient's right side, and a 5-millimeter trocar in the little finger over the left side. The pneumoperitoneum was established. A 10-millimeter rigid laparoscope was inserted via the 10-millimeter trocar and controlled by the assistant. The ancillary 5-millimeter port was made over the left lower abdomen under laparoscope inspection. The surgeon performed the surgery via the two 5-millimeter trocars. | Procedure or surgery | LETS-M |
Primary outcome
Operation time
Time frame: 1 day (the operation day)
The operation time was defined as the period from the incision to the closure of the skin.
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 Feb 2020.
- Results publication: PubMed 31181399Lee D, Lee JR, Suh CS, Kim SH. A systematic review and meta-analysis comparing single port laparoscopic myomectomy with conventional laparoscopic myomectomy. Eur J Obstet Gynecol Reprod Biol. 2019 Aug;239:52-59. doi: 10.1016/j.ejogrb.2019.06.001. Epub 2019 Jun 3.
- Results publication: PubMed 11214143Stewart EA. Uterine fibroids. Lancet. 2001 Jan 27;357(9252):293-8. doi: 10.1016/S0140-6736(00)03622-9.
- Results publication: PubMed 20440899Chang WC, Huang SC, Sheu BC. Advances in gynecological laparoscopic surgery. J Formos Med Assoc. 2010 Apr;109(4):245-7. doi: 10.1016/s0929-6646(10)60049-6. No abstract available.
- Results publication: PubMed 20576473Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):587-92. doi: 10.1016/j.jmig.2010.04.009. Epub 2010 Jun 23.
- Results publication: PubMed 21345435Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
- Results publication: PubMed 27327965Huang PS, Sheu BC, Huang SC, Chang WC. Intraligamental Myomectomy Strategy Using Laparoscopy. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):954-61. doi: 10.1016/j.jmig.2016.06.007. Epub 2016 Jun 18.
- Individual participant dataSharing planned: No. The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Wen-Chun Chang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Myoma, 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 2 inclusion and 4 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 Feb 2020. 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. 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?
Operation time (time frame: 1 day (the operation day)). 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 NCT04279626, which also lists 6 linked publications.
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 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.