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Mode of Uterine Extraction in Total Laparoscopic Hysterectomy

Sponsor
Università degli Studi di Ferrara (Other)
Overall Status
Recruiting
CT.gov ID
NCT05681910
Collaborator
(none)
200
Enrollment
1
Location
23
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Intraoperative complications [During surgery]

      mean operation time, uterus removal time, blood loss

    2. Post operative complications [30 days after surgery]

      Pelvic hematoma, vaginal stump infection, lower limb venous thrombosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients undergoing total laparoscopic hysterectomies for larger uteri
    Exclusion Criteria:
    • oncology

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy Ferrara Italy

    Sponsors and Collaborators

    • Università degli Studi di Ferrara

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gennaro Scutiero, MD, Università degli Studi di Ferrara
    ClinicalTrials.gov Identifier:
    NCT05681910
    Other Study ID Numbers:
    • 879/2022/Oss/AOUFe
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 12, 2023