Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

Last updated: April 15, 2015
Sponsor: CHA University
Overall Status: Terminated

Phase

3

Condition

Uterine Fibroids

Leiomyomas

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01858454
KNC13-012
  • Ages 18-70
  • Female

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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria: Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormalendometrial thickness, and suspected ovarian or uterine malignancy), any sign of genitalinfection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment ofgonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability tounderstand and provide written informed consent.

Study Design

Total Participants: 21
Study Start date:
March 01, 2013
Estimated Completion Date:
April 30, 2015

Study 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).

Connect with a study center

  • CHA Gangnam Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

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