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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-23

Study Completion Date

2019-06-11

Brief Summary

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

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Detailed Description

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

Conditions

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Benign or Preinvasive Uterine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-port LAVH group

single-port laparoscopic assisted vaginal hysterectomy

Group Type EXPERIMENTAL

Single-port LAVH

Intervention Type PROCEDURE

LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.

Three-port LAVH group

three-port laparoscopic assisted vaginal hysterectomy

Group Type ACTIVE_COMPARATOR

Three-port LAVH

Intervention Type PROCEDURE

Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.

Interventions

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Single-port LAVH

LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.

Intervention Type PROCEDURE

Three-port LAVH

Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No