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

Not Applicable

• Conditions: Benign Ovarian or Tubal Disease
• Interventions: Procedure: Three-port laparoscopic adnexal surgery; Procedure: Single-port laparoscopic adnexal surgery

• Registration Number: NCT01679509
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-port surgery group	Three-port laparoscopic adnexal surgery	Three-port laparoscopic adnexal surgery
Single-port surgery group	Single-port laparoscopic adnexal surgery	Single-port laparoscopic adnexal surgery

Primary Outcome Measures

Name	Time	Method
postoperative hospital stay	within 1 week after surgery

Secondary Outcome Measures

Name	Time	Method
postoperative pain	within 1 week after surgery
postoperative analgesics requirement	within 1 week after surgery
quality of life	within 6 months aftr surgery
surgical stress response	within 2 days after surgery
operating time	immediately ater surgery
transfusion requirement and amount	within 1 week after surgery
postoperative complication	within 1 months after surgery

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of