Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01483417
NCT01483417UnknownPhase 3

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

Samsung Medical Center9 sites in 1 country240 target enrollmentStarted: December 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
240
Locations
9
Primary Endpoint
Conversion rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

Conversion rate

Time Frame: 1 week

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

Secondary Outcomes

  • Patient and Observer Scar Assessment Scale (POSAS)(12 weeks)
  • Postoperative pain(postop. 1 day, 1 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tae-Joong Kim

Clinical Assistant Professor

Samsung Medical Center

Study Sites (9)

Loading locations...

Similar Trials

Approved For Marketing
Not Applicable
Multicenter Single-port Colectomy RCTColon Neoplasms
NCT01480128The Catholic University of Korea
Completed
Phase 4
Prospective Randomized Study of SILS Versus CLS for Rectal CancerRectal CancerAdenocarcinoma
NCT01579721Hvidovre University Hospital40
Unknown
Phase 3
Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric CancerSurgery
NCT05035446Fujian Cancer Hospital120
Completed
Not Applicable
Single Incision Versus Conventional Laparoscopic AppendectomyAcute Appendicitis
NCT01424631Mansoura University2
Unknown
Not Applicable
A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)Inguinal Hernia
NCT01883115The Sydney Hernia Specialists Clinic102