Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign or Preinvasive Uterine Disease | Procedure: Single-port LAVH Procedure: Three-port LAVH | Not Applicable |
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 |

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
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Procedure: Three-port LAVH |
- postoperative hospital stay [ Time Frame: within 1 week after surgery ]
- 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 ]

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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 |
Inclusion Criteria:
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Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
- uterine leiomyoma
- uterine adenomyosis
- Endometrial hyperplasia
- cervical intraepithelial neoplasia including carcinoma in situ and FIGO stage IA1 cancer
- Dysfunctional uterine bleeding
- 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

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
Contact: Joo-Hyun Nam, M.D., Ph.D. | 82-2-3010-3633 | jhnam@amc.seoul.kr |
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 |
Principal Investigator: | Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center |
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 |
Uterine Diseases |