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Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Joo-Hyun Nam, 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: May 27, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery

Further study details as provided by Joo-Hyun Nam, Asan Medical Center:

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

Secondary Outcome Measures:
  • 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: immediately ater surgery ]
  • transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  • postoperative complication [ Time Frame: within 1 months after surgery ]

Estimated Enrollment: 330
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: May 27, 2017

ClinicalTrials.gov processed this record on June 23, 2017