Uterine MyomaPhase 3NCT01483417
Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy
A Phase 3 study testing Single incision Laparoscopic hysterectomy and Conventional laparoscopic hysterectomy in people with Uterine Myoma and Uterine Adenomyosis, run by Samsung Medical Center at 8 sites in South Korea.
Trial summary
Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Uterine Myoma, Uterine Adenomyosis
- What is being tested?
- Single incision Laparoscopic hysterectomy and Conventional laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Dec 2011to Mar 2013
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
- Uterine size < gestational age of 14 weeks
- Informed consent
Who cannot join
- Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
- Huge uterine size > gestational age of 14 weeks
Trial locations and contacts
8 sites in 1 country.
Chi-Heum Cho, MD, PhD contact
Sang Hun Kwon, MD, PhD contact
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Deagu
Chi-Heum Cho, MD,PhD
- Not yet recruiting
Catholic Incheon Hospital
Incheon
Yong Wook Kim
- Recruiting
Samsung Medical Center
Seoul, 135-710
Tae Joong Kim, MD, 82-2-3410-3547, tj28.kim@gmail.com
Tae Joong Kim
- Not yet recruiting
Asan Medical Center
Seoul
Yong Man Kim
- Recruiting
Kangnam Cha Hospital
Seoul
Suk Joo Sung
- Not yet recruiting
Seoul Catholic Medical Center
Seoul
Soo Young Hur
- Not yet recruiting
Yonsei University Medical Center
Seoul
Sang Wun Kim
- Not yet recruiting
Seoul University Bundang Hospital
Seungnam
Yong Beom Kim
About this study
Official title: Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis
Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.
- Conditions
- Uterine Myoma, Uterine Adenomyosis
- Being tested
- Single incision Laparoscopic hysterectomy, Conventional laparoscopic hysterectomy
- Keywords
- SILS, Laparoscopic hysterectomy, Cosmetic outcome, Pain
- 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.
Single incision Laparoscopic hysterectomyProcedure or surgery
SILS port
Conventional laparoscopic hysterectomyProcedure or surgery
3-4 conventional ports
| Study group | Role | What they receive |
|---|---|---|
| SILS | Experimental | Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port Receives: Procedure: Single incision Laparoscopic hysterectomy |
| Conventional multi-port laparoscopic hysterectomy | Active comparator | 3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH Receives: Procedure: Conventional laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Conversion means that events required additional port(s) or open laparotomy
Measured: 1 week
Secondary outcomes (2)
Patient and Observer Scar Assessment Scale (POSAS)
Measured: 12 weeks
Postoperative pain
Measured by numeric rating score (NRS)
Measured: postop. 1 day, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Joong Kim, Samsung Medical Center
- Investigators
- Chi-Heum Cho, MD, PhD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483417
- Sponsor's protocol ID
- 2011-10-004
- Status last verified
- Nov 2011
- First submitted
- 29 Nov 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim TJ, Lee YY, Cha HH, Kim CJ, Choi CH, Lee JW, Bae DS, Lee JH, Kim BG. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010 Sep;24(9):2248-52. doi: 10.1007/s00464-010-0944-y. Epub 2010 Feb 23.
PubMed 20177921Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.
PubMed 19487164Jung YW, Lee M, Yim GW, Lee SH, Paek JH, Kwon HY, Nam EJ, Kim SW, Kim YT. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011 Aug;25(8):2462-9. doi: 10.1007/s00464-010-1567-z. Epub 2011 Feb 7.
PubMed 21298522Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):906-912. doi: 10.1097/AOG.0b013e31820c666a.
PubMed 21422864
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis
- ClinicalTrials.gov ID
- NCT01483417
- Acronym / sponsor ID
- 2011-10-004
- Conditions
- Uterine Myoma, Uterine Adenomyosis
- Keywords
- SILS, Laparoscopic hysterectomy, Cosmetic outcome, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 1 Dec 2011 (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.
Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILS | Experimental | Procedure: Single incision Laparoscopic hysterectomyLaparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port |
| Conventional multi-port laparoscopic hysterectomy | Active comparator | Procedure: Conventional laparoscopic hysterectomy3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
- Uterine size < gestational age of 14 weeks
- Informed consent
Key exclusion criteria (2 listed)
- Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
- Huge uterine size > gestational age of 14 weeks
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 |
|---|---|---|
| Single incision Laparoscopic hysterectomySILS port | Procedure or surgery | SILS |
| Conventional laparoscopic hysterectomy3-4 conventional ports | Procedure or surgery | Conventional multi-port laparoscopic hysterectomy |
Primary outcome
Conversion rate
Time frame: 1 week
Conversion means that events required additional port(s) or open laparotomy
2 secondary outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 12 weeks
Postoperative pain
Time frame: postop. 1 day, 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Background: PubMed 20177921Kim TJ, Lee YY, Cha HH, Kim CJ, Choi CH, Lee JW, Bae DS, Lee JH, Kim BG. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010 Sep;24(9):2248-52. doi: 10.1007/s00464-010-0944-y. Epub 2010 Feb 23.
- Background: PubMed 19487164Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.
- Background: PubMed 21298522Jung YW, Lee M, Yim GW, Lee SH, Paek JH, Kwon HY, Nam EJ, Kim SW, Kim YT. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011 Aug;25(8):2462-9. doi: 10.1007/s00464-010-1567-z. Epub 2011 Feb 7.
- Background: PubMed 21422864Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):906-912. doi: 10.1097/AOG.0b013e31820c666a.
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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.
Chi-Heum Cho, MD, PhD contact
Sang Hun Kwon, MD, PhD contact
Chi-Heum Cho, MD, PhD principal investigator
Keimyung University Dongsan Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single incision Laparoscopic hysterectomy and Conventional laparoscopic hysterectomy in people with Uterine Myoma and Uterine Adenomyosis, run by Samsung Medical Center at 8 sites 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Heum Cho, MD, PhD (c0035@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: 1 week). 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 NCT01483417, which also lists 4 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 22 Feb 2012.