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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01064128

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Myoma Uterine Adenomyosis	Procedure: conventional laparoscopic hysterectomy Procedure: SPA laparoscopic hysterectomy	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional laparoscopic hysterectomy Three or four ports conventional laparoscopic hysterectomy	Procedure: conventional laparoscopic hysterectomy conventional 3 or 4 ports laparoscopic hysterectomy
Active Comparator: SPA laparoscopic hysterectomy Single umbilical incision laparoscopic hysterectomy	Procedure: SPA laparoscopic hysterectomy single-port access laparoscopic hysterectomy

Arm

Intervention/Treatment

Active Comparator: conventional laparoscopic hysterectomy

Three or four ports conventional laparoscopic hysterectomy

Procedure: conventional laparoscopic hysterectomy

conventional 3 or 4 ports laparoscopic hysterectomy

Active Comparator: SPA laparoscopic hysterectomy

Single umbilical incision laparoscopic hysterectomy

Procedure: SPA laparoscopic hysterectomy

single-port access laparoscopic hysterectomy

Outcome Measures

Primary Outcome Measures

Pain score measured by visual analog scale [postoperative 24 hours]

Secondary Outcome Measures

Modified body image scale and cosmetic scar scale [postoperative 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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