Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Samsung Medical Center240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Uterine Myoma Uterine Adenomyosis

Interventions

Single incision Laparoscopic hysterectomyPROCEDURE

SILS port

Conventional laparoscopic hysterectomyPROCEDURE

3-4 conventional ports

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (8)

Keimyung University Dongsan Hospital

Deagu, South Korea

RECRUITING

Catholic Incheon Hospital

Incheon, South Korea

NOT_YET_RECRUITING

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Conversion rate

Conversion means that events required additional port(s) or open laparotomy

Time frame: 1 week

Secondary Outcomes

Patient and Observer Scar Assessment Scale (POSAS)

Time frame: 12 weeks

Postoperative pain

Measured by numeric rating score (NRS)

Time frame: postop. 1 day, 1 week

Central Contacts

Chi-Heum Cho, MD, PhD

CONTACT

c0035@dsmc.or.kr

Sang Hun Kwon, MD, PhD

CONTACT

ksh1999@dsmc.or.kr

Data from ClinicalTrials.gov

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