Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
Phase 3
Completed
- Conditions
- Uterine MyomaUterine Adenomyosis
- Registration Number
- NCT01064128
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Purpose:
The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain score measured by visual analog scale postoperative 24 hours
- Secondary Outcome Measures
Name Time Method Modified body image scale and cosmetic scar scale postoperative 6 months
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic of