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Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01483417
Enrollment
240
Registered
2011-12-01
Start date
2011-12-31
Completion date
2013-03-31
Last updated
2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Adenomyosis, Uterine Myoma

Keywords

SILS, Laparoscopic hysterectomy, Cosmetic outcome, Pain

Brief summary

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.

Interventions

PROCEDURESingle incision Laparoscopic hysterectomy

SILS port

PROCEDUREConventional laparoscopic hysterectomy

3-4 conventional ports

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Conversion rate1 weekConversion means that events required additional port(s) or open laparotomy

Secondary

MeasureTime frameDescription
Patient and Observer Scar Assessment Scale (POSAS)12 weeks—
Postoperative painpostop. 1 day, 1 weekMeasured by numeric rating score (NRS)

Countries

South Korea

Contacts

Primary ContactChi-Heum Cho, MD, PhD
c0035@dsmc.or.kr
Backup ContactSang Hun Kwon, MD, PhD
ksh1999@dsmc.or.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026