NCT01858454

Brief Summary

The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.

Trial Health

57
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Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

May 17, 2013

Last Update Submit

April 15, 2015

Conditions

Uterine Myomas

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction about surgery

    1 month after surgery

Study Arms (2)

HALS for myomectomy

EXPERIMENTAL

Hand-assisted laparoscopic surgery for myomectomy

Procedure: HALS

Open myomectomy

ACTIVE COMPARATOR

Open surgery for myomectomy

Procedure: Open surgery

Interventions

HALSPROCEDURE

In HALS, a trocar of 5-mm calipers was inserted through the umbilicus. Next, suprapubic transverse skin incision of 3-4cm in length was made and a wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) was inserted through the suprapubic opening.

HALS for myomectomy
Open surgeryPROCEDURE

In open surgery, the patient was placed in the supine position and the operation was carried out in a standard manner as described elsewhere \[Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.\].

Open myomectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Gangnam Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Taejong Song, MD

    CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

KR(1)