Surgical Outcome of Two-port Laparoscopic Myomectomy

February 19, 2020 updated by: National Taiwan University Hospital

The Surgical Outcome of Two-port Laparoscopic Myomectomy Using Conventional Laparoscopic Instruments and Glove-port Technique

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency and constipation, received LETS-M for their uterine myoma.

Description

Inclusion Criteria:

  • Women older than 20 years old and had not reached menopause
  • Symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation.

Exclusion Criteria:

  • Dominant symptoms with active pelvic or urinary tract infection
  • A history of pelvic radiotherapy
  • A preexisting or suspicious malignant pelvic tumor
  • Pathologies other than uterine myoma noted during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LETS-M
Women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation, received LETS-M.
Procedure: LETS-M
A 1.5-centimeter skin incision was made over the umbilicus, and the abdominal wall was opened layer by layer with an open method. A wound retractor (Alexis, 2-4 centimeter; Applied Medical Resources Corp., Rancho Santa Margarita, CA) was placed, and the glove port was set up, with a 10-millimeter trocar in the thumb over patient's right side, and a 5-millimeter trocar in the little finger over the left side. The pneumoperitoneum was established. A 10-millimeter rigid laparoscope was inserted via the 10-millimeter trocar and controlled by the assistant. The ancillary 5-millimeter port was made over the left lower abdomen under laparoscope inspection. The surgeon performed the surgery via the two 5-millimeter trocars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: 1 day (the operation day)
The operation time was defined as the period from the incision to the closure of the skin.
1 day (the operation day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Wen-Chun Chang, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2015

Primary Completion (Actual)

September 23, 2019

Study Completion (Actual)

September 23, 2019

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001027RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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