A Phase 3 interventional study of Single incision Laparoscopic hysterectomy and Conventional laparoscopic hysterectomy in Uterine Myoma and Uterine Adenomyosis, sponsored by Samsung Medical Center. Status unknown at 8 sites in Korea, Republic of. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-02-22.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment
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.
142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 78 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port
Procedure: Single incision Laparoscopic hysterectomy
3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH
Procedure: Conventional laparoscopic hysterectomy
SILS port
3-4 conventional ports
Conversion rate
Conversion means that events required additional port(s) or open laparotomy
Time frame: 1 week
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 12 weeks
Postoperative pain
Measured by numeric rating score (NRS)
Time frame: postop. 1 day, 1 week
The record gives a start of Dec 2011, a primary completion of Dec 2012 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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