Uterine MyomasPhase 3NCT01858454
Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy
A Phase 3 study testing HALS and Open surgery in people with Uterine Myomas, run by CHA University at 1 site in South Korea.
Trial summary
The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Myomas
- What is being tested?
- HALS and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Apr 2015
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).
Who cannot join
- Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions
The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.
Read the detailed description
Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.
Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.
In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).
- Conditions
- Uterine Myomas
- Being tested
- HALS, Open surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALSProcedure or surgery
In HALS, a trocar of 5-mm calipers was inserted through the umbilicus. Next, suprapubic transverse skin incision of 3-4cm in length was made and a wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) was inserted through the suprapubic opening.
Open surgeryProcedure or surgery
In open surgery, the patient was placed in the supine position and the operation was carried out in a standard manner as described elsewhere [Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.].
| Study group | Role | What they receive |
|---|---|---|
| HALS for myomectomy | Experimental | Hand-assisted laparoscopic surgery for myomectomy Receives: Procedure: HALS |
| Open myomectomy | Active comparator | Open surgery for myomectomy Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction about surgery
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: The study enrollment is not enough
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, CHA University
- Investigators
- Taejong Song, MD, Principal investigator, CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858454
- Sponsor's protocol ID
- KNC13-012
- Status last verified
- Apr 2015
- First submitted
- 17 May 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions
- ClinicalTrials.gov ID
- NCT01858454
- Acronym / sponsor ID
- KNC13-012
- Conditions
- Uterine Myomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study enrollment is not enough
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 May 2013 (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 was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.
Detailed description
Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.
Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.
In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HALS for myomectomy | Experimental | Procedure: HALSHand-assisted laparoscopic surgery for myomectomy |
| Open myomectomy | Active comparator | Procedure: Open surgeryOpen surgery for myomectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).
Key exclusion criteria (1 listed)
- Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
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 |
|---|---|---|
| HALSIn HALS, a trocar of 5-mm calipers was inserted through the umbilicus. Next, suprapubic transverse skin incision of 3-4cm in length was made and a wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) was inserted through the suprapubic opening. | Procedure or surgery | HALS for myomectomy |
| Open surgeryIn open surgery, the patient was placed in the supine position and the operation was carried out in a standard manner as described elsewhere [Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.]. | Procedure or surgery | Open myomectomy |
Primary outcome
Patient satisfaction about surgery
Time frame: 1 month after surgery
Results and safety
The study was stopped early (reason given: The study enrollment is not enough). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
Taejong Song, MD principal investigator
CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HALS and Open surgery in people with Uterine Myomas, run by CHA University at 1 site in South Korea.
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: stopped early, as of the sponsor's last update on 16 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: The study enrollment is not enough). Results are not available in the source record.
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?
Patient satisfaction about surgery (time frame: 1 month after surgery). 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 16 Apr 2015.