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

Primary Purpose

Uterine Myoma, Uterine Adenomyosis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

conventional laparoscopic hysterectomy

SPA laparoscopic hysterectomy

About this trial

This is an interventional treatment trial for Uterine Myoma focused on measuring Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

conventional laparoscopic hysterectomy

SPA laparoscopic hysterectomy

Arm Description

Three or four ports conventional laparoscopic hysterectomy

Single umbilical incision laparoscopic hysterectomy

Outcomes

Primary Outcome Measures

Pain score measured by visual analog scale

Secondary Outcome Measures

Modified body image scale and cosmetic scar scale

Full Information

NCT ID

NCT01064128

First Posted

February 5, 2010

Last Updated

July 18, 2011

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01064128

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Myoma, Uterine Adenomyosis

Keywords

Single-port, Laparoscopy, Hysterectomy, Pain, Cosmesis, Analgesics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional laparoscopic hysterectomy

Arm Type

Active Comparator

Arm Description

Three or four ports conventional laparoscopic hysterectomy

Arm Title

SPA laparoscopic hysterectomy

Arm Type

Active Comparator

Arm Description

Single umbilical incision laparoscopic hysterectomy

Intervention Type

Procedure

Intervention Name(s)

conventional laparoscopic hysterectomy

Intervention Description

conventional 3 or 4 ports laparoscopic hysterectomy

Intervention Type

Procedure

Intervention Name(s)

SPA laparoscopic hysterectomy

Intervention Description

single-port access laparoscopic hysterectomy

Primary Outcome Measure Information:

Title

Pain score measured by visual analog scale

Time Frame

postoperative 24 hours

Secondary Outcome Measure Information:

Title

Modified body image scale and cosmetic scar scale

Time Frame

postoperative 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

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

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