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Spots Global Cancer Trial Database for Surgical Outcome of Two-port Laparoscopic Myomectomy

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Trial Identification

Brief Title: Surgical Outcome of Two-port Laparoscopic Myomectomy

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

Study ID: NCT04279626

Conditions

Uterine Myoma

Interventions

LETS-M

Study Description

Brief 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

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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

National Taiwan University Hospital, Taipei, , Taiwan

Contact Details

Name: Wen-Chun Chang, MD

Affiliation: National Taiwan University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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