Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

Phase 3TerminatedNCT01858454

CHA University21 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Uterine Myomas

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.

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 \[Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.\].

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHA Gangnam Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Patient satisfaction about surgery

Time frame: 1 month after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.