NCT01064128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

February 5, 2010

Last Update Submit

July 18, 2011

Conditions

Uterine MyomaUterine Adenomyosis

Keywords

Single-portLaparoscopyHysterectomyPainCosmesisAnalgesics

Outcome Measures

Primary Outcomes (1)

  • Pain score measured by visual analog scale

    postoperative 24 hours

Secondary Outcomes (1)

  • Modified body image scale and cosmetic scar scale

    postoperative 6 months

Study Arms (2)

conventional laparoscopic hysterectomy

ACTIVE COMPARATOR

Three or four ports conventional laparoscopic hysterectomy

Procedure: conventional laparoscopic hysterectomy

SPA laparoscopic hysterectomy

ACTIVE COMPARATOR

Single umbilical incision laparoscopic hysterectomy

Procedure: SPA laparoscopic hysterectomy

Interventions

conventional laparoscopic hysterectomyPROCEDURE

conventional 3 or 4 ports laparoscopic hysterectomy

conventional laparoscopic hysterectomy
SPA laparoscopic hysterectomyPROCEDURE

single-port access laparoscopic hysterectomy

SPA laparoscopic hysterectomy

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

MyofibromaAdenomyosisPain

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

KR(1)