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

NCT ID: NCT03901404

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-04-01

Brief Summary

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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

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Conditions

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Myoma;Uterus Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Myomectomy Operation

Patients undergoing myomectomy for myoma uteri

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and GynecologyR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.12.67

Identifier Type: -

Identifier Source: org_study_id

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