Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Phase 3
30 Years
60 Years
30 Years
60 Years
Not Enrolling
Female
Uterine Myoma, Uterine Adenomyosis
Female
Uterine Myoma, Uterine Adenomyosis
Trial Information
Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Inclusion Criteria:
- Age 30-60, female
- Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom,
Increasing size, Menorrhagia) myomas or adenomyosis
- Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
- At least a 6-month thorough follow-up record available
- Informed consent
Exclusion Criteria:
- Endometrial hyperplasia without myoma or adenomyosis
- Body Mass Index more than 30
- Huge uterus defined by longitudinal uterine diameter larger than 10cm and
anteroposterior diameter larger than 8cm in USG
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pain score measured by visual analog scale
Outcome Time Frame:
postoperative 24 hours
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
2009-09-093
NCT ID:
NCT01064128
Start Date:
January 2010
Completion Date:
December 2010
Related Keywords:
- Uterine Myoma
- Uterine Adenomyosis
- Single-port
- Laparoscopy
- Hysterectomy
- Pain
- Cosmesis
- Analgesics
- Myoma
- Leiomyoma
- Myofibroma
- Endometriosis
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