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Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal 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:
NCT01679509
First received: September 3, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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


Condition Intervention
Benign Ovarian or Tubal Disease
 Procedure: Single-port laparoscopic adnexal surgery
Procedure: Three-port laparoscopic adnexal surgery

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 Adnexal Surgery

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: 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 ]

Estimated Enrollment: 330
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 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

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679509

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, 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     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: NCT01679509     History of Changes
Other Study ID Numbers: LESS-A
Study First Received: September 3, 2012
Last Updated: September 3, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013