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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILS | Experimental | Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port |
|
| Conventional multi-port laparoscopic hysterectomy | Active Comparator | 3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single incision Laparoscopic hysterectomy | Procedure | SILS port |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | Conversion means that events required additional port(s) or open laparotomy | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | 12 weeks | |
| Postoperative pain | Measured by numeric rating score (NRS) | postop. 1 day, 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-Heum Cho, MD, PhD | Contact | c0035@dsmc.or.kr | ||
| Sang Hun Kwon, MD, PhD | Contact | ksh1999@dsmc.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Chi-Heum Cho, MD, PhD | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Hospital | Recruiting | Deagu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20177921 | Background | 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. | |
| 19487164 |
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| Conventional laparoscopic hysterectomy |
| Procedure |
3-4 conventional ports |
|
| Catholic Incheon Hospital | Not yet recruiting | Incheon | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
|
| Asan Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Kangnam Cha Hospital | Recruiting | Seoul | South Korea |
|
| Seoul Catholic Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Yonsei University Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Seoul University Bundang Hospital | Not yet recruiting | Seungnam | South Korea |
|
| Lee 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. |
| 21298522 | Background | Jung 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. |
| 21422864 | Background | Chen 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. |
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| D062788 | Adenomyosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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