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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

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

Condition or disease Intervention/treatment Phase
Benign or Preinvasive Uterine Disease Procedure: Single-port LAVH Procedure: Three-port LAVH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
Study Start Date : September 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. postoperative hospital stay [ Time Frame: within 1 week after surgery ]

Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: within 1 week after surgery ]
  2. postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  3. quality of life [ Time Frame: within 6 months aftr surgery ]
  4. surgical stress response [ Time Frame: within 2 days after surgery ]
  5. operating time [ Time Frame: 1 day (immediately ater surgery) ]
  6. Transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  7. postoperative complication [ Time Frame: within 1 months after surgery ]
  8. time interval to return to work [ Time Frame: within 2 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679548


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

Locations
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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
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Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
More Information
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01679548    
Other Study ID Numbers: LESS-H
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Uterine Diseases
Genital Diseases, Female