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

Completed

• Conditions: Surgery; Myoma;Uterus

• Registration Number: NCT03901404
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients operated with the diagnosis of myoma uteri

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey