Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction

Surgery Clinical Trial

Official title:

Used During Myomectomy Operation; Comparison of Fundus Incision, Energy Modalities and Methods of Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901404
• Other study ID #: 2018.12.67
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss. For some anatomical reasons, fundal myomas were removed, while a group of investigators recommended the initiation of a longitudinal incision and some surgeons preferred a transverse incision. the authors aim to show some surgical differences, intraoperative blood loss, and difficulties and ease of removal of myoma in patients with these approaches without consensus. It is also noted that the incision made with the same energy modality is recorded; The effect of energy modality on blood loss and surgical comfort will be examined. Different approaches are used for laparoscopic surgical operations in order to remove myoma from the abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the abdomen by a morselator. In particular, patients with vaginal myoma removed, such as complaints of postoperative dyspareunia will be followed. In this way, the investigators aim to evaluate the methods which have not yet gained clarity in the literature or have not proven superiority to each other.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients operated with the diagnosis of myoma uteri

Exclusion Criteria:

• Cardiopulmonary diseases such as cardiac insufficiency, myocardial infarction, unstable angina, acute or new vascular thrombosis, asthma or pulmonary obstructive disease;

• Patients with long-term Trendelenburg contraindications;

• Previous pelvic or abdominal radiation therapy; or those with inadequate bone marrow, kidney and hepatic function;

• Gynecological malignancies.

• Those who received preoperative medication due to myoma uteri

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Surgery
• Surgical Wound

Intervention

Procedure:
• Myomectomy Operation
Patients undergoing myomectomy for myoma uteri

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundus Incision	In patients undergoing myomectomy, the incision used by the surgeon will be recorded to remove myoma. to be recorded as transverse or vertical.	3 months
Primary	Energy Modalities	In patients undergoing myomectomy, the energy modality used by the surgeon will be recorded to remove the myoma.; bipolari, monopolar or ultrasonic	3 months
Primary	Methods of Extraction	In patients undergoing myomectomy operation, the method used by the surgeon to remove myoma from the abdomen will be recorded.; morselator, vaginally with colpotomi	3 months