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Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679548
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
postoperative hospital stay [ Time Frame: within 1 week after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
postoperatie hospital stay [ Time Frame: within 1 week after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • postoperative pain [ Time Frame: within 1 week after surgery ]
  • postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  • quality of life [ Time Frame: within 6 months aftr surgery ]
  • surgical stress response [ Time Frame: within 2 days after surgery ]
  • operating time [ Time Frame: 1 day (immediately ater surgery) ]
  • Transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  • postoperative complication [ Time Frame: within 1 months after surgery ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • postoperative pain [ Time Frame: within 1 week after surgery ]
  • postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  • quality of life [ Time Frame: within 6 months aftr surgery ]
  • surgical stress resposne [ Time Frame: within 2 days after surgery ]
  • operating time [ Time Frame: 1 day (immediately ater surgery) ]
  • Transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  • postoperative complication [ Time Frame: within 1 months after surgery ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
Official Title  ICMJE Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
Brief Summary To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign or Preinvasive Uterine Disease
Intervention  ICMJE
  • Procedure: Single-port LAVH
  • Procedure: Three-port LAVH
Study Arms  ICMJE
  • Experimental: Single-port LAVH group
    single-port laparoscopic assisted vaginal hysterectomy
    Intervention: Procedure: Single-port LAVH
  • Active Comparator: Three-port LAVH group
    three-port laparoscopic assisted vaginal hysterectomy
    Intervention: Procedure: Three-port LAVH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
424
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease

    1. uterine leiomyoma
    2. uterine adenomyosis
    3. Endometrial hyperplasia
    4. cervical intraepithelial neoplasia including carcinoma in situ and FIGO stage IA1 cancer
    5. Dysfunctional uterine bleeding
    6. Other benign gynecologic disease requiring hysterectomy
  • American Society of Anesthesiologists Physical Status classification I-II
  • Patient who have signed an written informed consent

Exclusion Criteria:

  • Uncontrolled medical disease
  • Active infectious disease
  • Previous pelvic radiation therapy
  • Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
  • Patient who undergoes subtotal hysterectomy
  • Patient who have other pain source excluding gynecologic disease
  • Pregnancy and lactating woman
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679548
Other Study ID Numbers  ICMJE LESS-H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joo-Hyun Nam, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP