Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy
|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|
- Patient satisfaction about surgery [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: HALS for myomectomy
Hand-assisted laparoscopic surgery for myomectomy
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.].
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858454
|Korea, Republic of|
|CHA Gangnam Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Taejong Song, MD||CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea|