Surgical Outcome of Two-port Laparoscopic Myomectomy

Status Completed

Clinical Trial Summary

Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees.

Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M

Clinical Trial Description

Laparoscopic myomectomy (LM) is an alternative and advanced technique that can take the place of traditional open surgery and achieve the goal of minimally invasive operation for women who wish to preserve the uterus. However, LM is considered a time-consuming procedure, requiring more suturing and knot-tying, and is better performed for woman with an appropriate uterine size by experienced surgeons.

Laparoendoscopic two-sites myomectomy (LETS-M) is a novel setting for LM on a two-port basis, using the umbilical glove port, three trocars, and conventional laparoscopic equipment.

Between January 2015 and September 2019, the medical records of women with uterine myoma managed by LETS-M were retrospectively reviewed.

The review of the chart records consisted of a detailed history, such as age, body mass index (BMI), gravidity, parity, marital status, sexual experience, previous abdominal surgery, and hospital stay after the surgery. All women received preoperative ultrasound for their uterine myoma assessment, including the location, type, size, number, and accompanying pathology, such as an ovarian tumor. The myoma locations were identified during the operation and classified into fundal wall myoma, anterior wall myoma, posterior wall myoma, and cervical myoma. The myoma type classification was based on the International Federation of Gynecology and Obstetrics (FIGO) leiomyoma subclassification system. We measured the weight of the specimen after finishing the surgery. The operation time was defined as the period from the incision to the closure of the skin. Any intraoperative blood loss less than 50mL or minimal blood loss on operation note was recorded as 50 milliliters in this study. Excessive blood loss was defined as more or equal to 500 milliliters in the operation. The postoperative pain scale was evaluated by a visual analog scale (VAS) on the first and second postoperative days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04279626
Study type	Observational
Source	National Taiwan University Hospital
Contact
Status	Completed
Phase
Start date	January 21, 2015
Completion date	September 23, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.