Uterine MyomaPhase 3NCT01064128
Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
A Phase 3 study testing conventional laparoscopic hysterectomy and SPA laparoscopic hysterectomy in people with Uterine Myoma and Uterine Adenomyosis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Purpose: The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Uterine Myoma, Uterine Adenomyosis
- What is being tested?
- conventional laparoscopic hysterectomy and SPA laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2010
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-60, female
- Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis
- Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
- At least a 6-month thorough follow-up record available
- Informed consent
Who cannot join
- Endometrial hyperplasia without myoma or adenomyosis
- Body Mass Index more than 30
- Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Purpose:
The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.
- Conditions
- Uterine Myoma, Uterine Adenomyosis
- Being tested
- conventional laparoscopic hysterectomy, SPA laparoscopic hysterectomy
- Keywords
- Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics
- Medical subject headings
- Myofibroma, Adenomyosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopic hysterectomyProcedure or surgery
conventional 3 or 4 ports laparoscopic hysterectomy
SPA laparoscopic hysterectomyProcedure or surgery
single-port access laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| conventional laparoscopic hysterectomy | Active comparator | Three or four ports conventional laparoscopic hysterectomy Receives: Procedure: conventional laparoscopic hysterectomy |
| SPA laparoscopic hysterectomy | Active comparator | Single umbilical incision laparoscopic hysterectomy Receives: Procedure: SPA laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score measured by visual analog scale
Measured: postoperative 24 hours
Secondary outcomes (1)
Modified body image scale and cosmetic scar scale
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine MyomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064128
- Sponsor's protocol ID
- 2009-09-093
- Status last verified
- Jul 2011
- First submitted
- 5 Feb 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01064128
- Acronym / sponsor ID
- 2009-09-093
- Conditions
- Uterine Myoma, Uterine Adenomyosis
- Keywords
- Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Feb 2010 (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.
Purpose:
The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional laparoscopic hysterectomy | Active comparator | Procedure: conventional laparoscopic hysterectomyThree or four ports conventional laparoscopic hysterectomy |
| SPA laparoscopic hysterectomy | Active comparator | Procedure: SPA laparoscopic hysterectomySingle umbilical incision laparoscopic hysterectomy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 30-60, female
- Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis
- Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
- At least a 6-month thorough follow-up record available
- Informed consent
Key exclusion criteria (3 listed)
- Endometrial hyperplasia without myoma or adenomyosis
- Body Mass Index more than 30
- Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG
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 |
|---|---|---|
| conventional laparoscopic hysterectomyconventional 3 or 4 ports laparoscopic hysterectomy | Procedure or surgery | conventional laparoscopic hysterectomy |
| SPA laparoscopic hysterectomysingle-port access laparoscopic hysterectomy | Procedure or surgery | SPA laparoscopic hysterectomy |
Primary outcome
Pain score measured by visual analog scale
Time frame: postoperative 24 hours
1 secondary outcome
Modified body image scale and cosmetic scar scale
Time frame: postoperative 6 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 20 Jul 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 conventional laparoscopic hysterectomy and SPA laparoscopic hysterectomy in people with Uterine Myoma and Uterine Adenomyosis, run by Samsung Medical Center 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 5 inclusion and 3 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 20 Jul 2011. 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 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?
Pain score measured by visual analog scale (time frame: postoperative 24 hours). 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 20 Jul 2011.