Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Phase 3

Completed

• Conditions: Uterine Myoma; Uterine Adenomyosis
• Interventions: Procedure: conventional laparoscopic hysterectomy; Procedure: SPA laparoscopic hysterectomy

• 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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-20

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

Arm && Interventions

Group	Intervention	Description
conventional laparoscopic hysterectomy	conventional laparoscopic hysterectomy	Three or four ports conventional laparoscopic hysterectomy
SPA laparoscopic hysterectomy	SPA laparoscopic hysterectomy	Single umbilical incision laparoscopic hysterectomy

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