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Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal 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. Identifier: NCT01679509
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
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Brief Summary:
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease

Condition or disease Intervention/treatment Phase
Benign Ovarian or Tubal Disease Procedure: Single-port laparoscopic adnexal surgery Procedure: Three-port laparoscopic adnexal surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 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 Adnexal Surgery
Study Start Date : September 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Single-port surgery group
Single-port laparoscopic adnexal surgery
Procedure: Single-port laparoscopic adnexal surgery
Active Comparator: Three-port surgery group
Three-port laparoscopic adnexal surgery
Procedure: Three-port laparoscopic adnexal surgery

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: 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 ]

Information from the National Library of Medicine

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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:

  • Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease

    1. Benign teratoma
    2. Endometrioma
    3. Mucinous cystadenoma
    4. Serous cystadenoma
    5. Benign Brenner tumor
    6. Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
    7. paratubal cyst, parovarian cyst
    8. Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
    9. Other benign adnexal disease requiring surgery
  • American Society of Anesthesiologist Physical Status classification I-II.
  • Patient who have signed written informed consent

Exclusion Criteria:

  • Uncontrolled medical disease
  • Active infectious disease
  • Previous pelvic radiation therapy
  • Patient who requires further procedure excluding adnexal surgery
  • Patient who has other pain source excluding adnexal disease
  • Pregnant and lactating woman

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 identifier (NCT number): NCT01679509

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Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633

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Korea, Republic of
Department of Obstetrics and Gynecology, Universit 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   
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center Identifier: NCT01679509    
Other Study ID Numbers: LESS-A
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017