Surgical Outcome of Two-port Laparoscopic Myomectomy

NCT04279626 | Completed

• 1 other identifier: 202001027RINA
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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

Conditions

Uterine Myoma

Keywords

Laparoscopy; Two-port

Outcome Measures

Primary Outcomes (1)

• Operation time

  The operation time was defined as the period from the incision to the closure of the skin.

  1 day (the operation day)

Study Arms (1)

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

Interventions

LETS-M PROCEDURE

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.

LETS-M

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

• Lee D, Lee JR, Suh CS, Kim SH. A systematic review and meta-analysis comparing single port laparoscopic myomectomy with conventional laparoscopic myomectomy. Eur J Obstet Gynecol Reprod Biol. 2019 Aug;239:52-59. doi: 10.1016/j.ejogrb.2019.06.001. Epub 2019 Jun 3.

  PMID: 31181399 RESULT

• Stewart EA. Uterine fibroids. Lancet. 2001 Jan 27;357(9252):293-8. doi: 10.1016/S0140-6736(00)03622-9.

  PMID: 11214143 RESULT

• Chang WC, Huang SC, Sheu BC. Advances in gynecological laparoscopic surgery. J Formos Med Assoc. 2010 Apr;109(4):245-7. doi: 10.1016/s0929-6646(10)60049-6. No abstract available.

  PMID: 20440899 RESULT

• Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):587-92. doi: 10.1016/j.jmig.2010.04.009. Epub 2010 Jun 23.

  PMID: 20576473 RESULT

• Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.

  PMID: 21345435 RESULT

• Huang PS, Sheu BC, Huang SC, Chang WC. Intraligamental Myomectomy Strategy Using Laparoscopy. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):954-61. doi: 10.1016/j.jmig.2016.06.007. Epub 2016 Jun 18.

  PMID: 27327965 RESULT

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wen-Chun Chang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: January 21, 2015
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)