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

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.

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Key information

Conditions

Myoma;Uterus Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases Surgery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myomectomy Operation

Procedure

Patients undergoing myomectomy for myoma uteri

Primary outcomes

Fundus Incision

Time frame: 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.
Energy Modalities

Time frame: 3 months

In patients undergoing myomectomy, the energy modality used by the surgeon will be recorded to remove the myoma.

bipolari, monopolar or ultrasonic
Methods of Extraction

Time frame: 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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Apr 3, 2019
Registry last updated: Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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