Clinical trial NCT01483417: Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uterine Myoma
Uterine Adenomyosis
Keywords: SILS
Laparoscopic hysterectomy
Cosmetic outcome
Pain
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
* Huge uterine size \> gestational age of 14 weeks

Primary outcomes:
measure: Conversion rate
timeFrame: 1 week
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 12 weeks
measure: Postoperative pain
timeFrame: postop. 1 day, 1 week
Other outcomes:
Locations:
city: Deagu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Incheon Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangnam Cha Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Catholic Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center
city: Seungnam
country: Korea, Republic of
facility: Seoul University Bundang Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Chi-Heum Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.