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

Study Overview
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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

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.

Official Title
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Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy

Conditions
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Benign or Preinvasive Uterine Disease

Intervention / Treatment
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* Procedure: Single-port LAVH
* Procedure: Three-port LAVH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease uterine leiomyoma uterine adenomyosis Endometrial hyperplasia cervical intraepithelial neoplasia including carcinoma in situ Dysfunctional uterine bleeding 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-port LAVH group<br>single-port laparoscopic assisted vaginal hysterectomy | Procedure: Single-port LAVH<br>* LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.<br>|
| Active Comparator: Three-port LAVH group<br>three-port laparoscopic assisted vaginal hysterectomy | Procedure: Three-port LAVH<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hospital stay | The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups. | within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Postoperative pain was recorded using the Visual Analog Pain Scale (VAS), scored from 1 to 10 (0 is no pain and 10 is agonizing pain) | within 1 week after surgery | 
| postoperative analgesics requirement | Whenever patients requested additional analgesia, they were administered parenterally. | within 1 week after surgery | 
| operating time | skin to skin operation time was recorded | 1 day (immediately ater surgery) | 
| Transfusion requirement and amount | Transfusion requirement and amount were recorede | within 1 week after surgery | 
| intra and postoperative complication | intra and post operative complications were recorede | within 1 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LESS, Benign uterine disease, LAVH