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Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

NCT01858454 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-04-16

No results posted yet for this study

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.

Conditions

  • Uterine Myomas

Interventions

PROCEDURE

HALS

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.

PROCEDURE

Open surgery

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

Sponsors & Collaborators

  • CHA University

    lead OTHER

Principal Investigators

  • Taejong Song, MD · CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858454 on ClinicalTrials.gov