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

This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01679548
First received: September 3, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease


Condition Intervention
Benign or Preinvasive Uterine Disease
 Procedure: Single-port LAVH
Procedure: Three-port LAVH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • postoperative hospital stay [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative pain [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]
  • postoperative analgesics requirement [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: within 6 months aftr surgery ] [ Designated as safety issue: No ]
  • surgical stress response [ Time Frame: within 2 days after surgery ] [ Designated as safety issue: No ]
  • operating time [ Time Frame: 1 day (immediately ater surgery) ] [ Designated as safety issue: No ]
  • Transfusion requirement and amount [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: Yes ]
  • postoperative complication [ Time Frame: within 1 months after surgery ] [ Designated as safety issue: Yes ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 424
Study Start Date: September 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-port LAVH group
single-port laparoscopic assisted vaginal hysterectomy
 Procedure: Single-port LAVH
Active Comparator: Three-port LAVH group
three-port laparoscopic assisted vaginal hysterectomy
 Procedure: Three-port LAVH

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679548

Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 jhnam@amc.seoul.kr

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.     82-2-3010-3633     jhnam@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01679548     History of Changes
Other Study ID Numbers: LESS-H
Study First Received: September 3, 2012
Last Updated: September 10, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013