Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-03-31

Brief Summary

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Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.

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Detailed Description

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Conditions

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Uterine Myoma Uterine Adenomyosis

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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SILS

Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port

Group Type EXPERIMENTAL

Single incision Laparoscopic hysterectomy

Intervention Type PROCEDURE

SILS port

Conventional multi-port laparoscopic hysterectomy

3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH

Group Type ACTIVE_COMPARATOR

Conventional laparoscopic hysterectomy

Intervention Type PROCEDURE

3-4 conventional ports

Interventions

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Single incision Laparoscopic hysterectomy

SILS port

Intervention Type PROCEDURE

Conventional laparoscopic hysterectomy

3-4 conventional ports

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
* Uterine size \< gestational age of 14 weeks
* Informed consent

Exclusion Criteria

* Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
* Huge uterine size \> gestational age of 14 weeks

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Tae-Joong Kim

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi-Heum Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

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Keimyung University Dongsan Hospital

Deagu, , South Korea

Site Status RECRUITING