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NCT05681910 Clinical Trial

Mode of Uterine Extraction in Total Laparoscopic Hysterectomy

Hysterectomy Clinical Trial

Official title:
Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05681910
Other study ID # 879/2022/Oss/AOUFe
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date December 2024

Study information
Verified date January 2023
Source Università degli Studi di Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic. A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients undergoing total laparoscopic hysterectomies for larger uteri Exclusion Criteria: - oncology

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy Ferrara

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative complications mean operation time, uterus removal time, blood loss During surgery
Primary Post operative complications Pelvic hematoma, vaginal stump infection, lower limb venous thrombosis 30 days after surgery
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