Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

NCT ID: NCT01858454

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-04-30

Brief 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.

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).

Conditions

Uterine Myomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HALS for myomectomy

Hand-assisted laparoscopic surgery for myomectomy

Group Type: EXPERIMENTAL

HALS

Intervention Type: PROCEDURE

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 myomectomy

Open surgery for myomectomy

Group Type: ACTIVE_COMPARATOR

Open surgery

Intervention Type: PROCEDURE

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

Interventions

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.

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CHA University

OTHER

Sponsor Role: lead

Responsible Party

Taejong Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taejong Song, MD

Role: PRINCIPAL_INVESTIGATOR

CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea

Locations

CHA Gangnam Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KNC13-012

Identifier Type: -

Identifier Source: org_study_id