Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease

Asan Medical Center

Status

Completed

Conditions

Benign or Preinvasive Uterine Disease

Treatments

Procedure: Three-port LAVH

Procedure: Single-port LAVH

Study type

Interventional

Funder types

Other

Identifiers

NCT01679548

LESS-H

Details and patient eligibility

About

To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease

Full description

This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.

Enrollment

424 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
1. uterine leiomyoma
2. uterine adenomyosis
3. Endometrial hyperplasia
4. cervical intraepithelial neoplasia including carcinoma in situ
5. Dysfunctional uterine bleeding
6. Other benign gynecologic disease requiring hysterectomy
American Society of Anesthesiologists Physical Status classification I-II
Patient who have signed an written informed consent

Exclusion criteria

Uncontrolled medical disease
Active infectious disease
Previous pelvic radiation therapy
Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
Patient who undergoes subtotal hysterectomy
Patient who have other pain source excluding gynecologic disease
Pregnancy and lactating woman