Clinical Trials Logo
  1. Home
  2. Uterine Myoma
  3. NCT01483417
  4. Details
NCT01483417 Clinical Trial

Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Uterine Myoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01483417
Other study ID # 2011-10-004
Secondary ID
Status Recruiting
Phase Phase 3
First received November 29, 2011
Last updated February 20, 2012
Start date December 2011
Est. completion date March 2013

Study information
Verified date November 2011
Source Samsung Medical Center
Contact Chi-Heum Cho, MD, PhD
Email c0035@dsmc.or.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Single incision Laparoscopic hysterectomy
SILS port
• Conventional laparoscopic hysterectomy
3-4 conventional ports

Locations
Country Name City State
Korea, Republic of Keimyung University Dongsan Hospital Deagu
Korea, Republic of Catholic Incheon Hospital Incheon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangnam Cha Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul Catholic Medical Center Seoul
Korea, Republic of Yonsei University Medical Center Seoul
Korea, Republic of Seoul University Bundang Hospital Seungnam

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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):906-12. doi: 10.1097/AOG.0b013e31820c666a. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Conversion rate Conversion means that events required additional port(s) or open laparotomy 1 week Yes
Secondary Patient and Observer Scar Assessment Scale (POSAS) 12 weeks No
Secondary Postoperative pain Measured by numeric rating score (NRS) postop. 1 day, 1 week No
See also
  Status Clinical Trial Phase
Completed NCT01937104 - ONSD According to the Position During Laparoscopy N/A
Completed NCT01984632 - Barbed Suture in Single-port Laparoscopic Myomectomy Phase 3
Completed NCT01492179 - Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management. Phase 4
Recruiting NCT06099977 - Binaural Sound for Remimazolam Induction N/A
Completed NCT05086770 - Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere N/A
Withdrawn NCT03156127 - A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet Phase 1
Completed NCT05108597 - Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy Phase 3
Completed NCT02392585 - Single or Triple Uterine Tourniquet at Myomectomy N/A
Completed NCT02086435 - Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes N/A
Completed NCT01379313 - The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position N/A
Completed NCT04279626 - Surgical Outcome of Two-port Laparoscopic Myomectomy
Completed NCT01873378 - GnRH Agonist Pretreatment in Hysteroscopic Myomectomy N/A
Completed NCT01064128 - Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy Phase 3
Recruiting NCT01267851 - Clinical Database and Biobank of Patients With Gynecologic Neoplasms
Completed NCT01542658 - Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy N/A
Recruiting NCT02631278 - Radio Frequency Ablation (RFA STUDY ) N/A
Recruiting NCT01637974 - Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery N/A
Recruiting NCT02563392 - Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? N/A
Completed NCT02056717 - Use of Dexamethasone in Uterine Artery Embolization N/A