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

Asan Medical Center

Status: Unknown

Conditions: Benign Ovarian or Tubal Disease

Treatments: Procedure: Single-port laparoscopic adnexal surgery; Procedure: Three-port laparoscopic adnexal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01679509

LESS-A

Details and patient eligibility

About

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

Enrollment: 330 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Single-port surgery group

Experimental group

Description:

Single-port laparoscopic adnexal surgery

Treatment:

Procedure: Single-port laparoscopic adnexal surgery

Three-port surgery group

Active Comparator group

Description:

Three-port laparoscopic adnexal surgery

Treatment:

Procedure: Three-port laparoscopic adnexal surgery