Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01858454
First received: May 17, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Uterine Myomas
Procedure: HALS
Procedure: Open surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • Patient satisfaction about surgery [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HALS for myomectomy
Hand-assisted laparoscopic surgery for myomectomy
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.
Active Comparator: Open myomectomy
Open surgery for myomectomy
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.].

Detailed Description:

Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.

Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.

In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858454

Contacts
Contact: Taejong Song, M.D. +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Taejong Song, M.D.    +81-10-403508405    taejong.song@gmail.com   
Principal Investigator: Taejong Song, M.D.         
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01858454     History of Changes
Other Study ID Numbers: KNC13-012
Study First Received: May 17, 2013
Last Updated: November 21, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 29, 2014