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

NCT03901404 | Completed

• 1 other identifier: 2018.12.67
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myoma;Uterus; Surgery

Keywords

Myomectomy; Fundus Incision; Energy Modalities; Methods of Extraction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Myomectomy Operation PROCEDURE

Patients undergoing myomectomy for myoma uteri

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated with the diagnosis of myoma uteri

You may qualify if:

• \- Patients operated with the diagnosis of myoma uteri

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, M.D, Department of Obstetrics and GynecologyR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

TU (1)