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

NCT ID: NCT01064128

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Uterine Myoma Uterine Adenomyosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional laparoscopic hysterectomy

Three or four ports conventional laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

conventional laparoscopic hysterectomy

Intervention Type PROCEDURE

conventional 3 or 4 ports laparoscopic hysterectomy

SPA laparoscopic hysterectomy

Single umbilical incision laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

SPA laparoscopic hysterectomy

Intervention Type PROCEDURE

single-port access laparoscopic hysterectomy

Interventions

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conventional laparoscopic hysterectomy

conventional 3 or 4 ports laparoscopic hysterectomy

Intervention Type PROCEDURE

SPA laparoscopic hysterectomy

single-port access laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-09-093

Identifier Type: -

Identifier Source: org_study_id

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