Mode of Uterine Extraction in Total Laparoscopic Hysterectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hysterectomy

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy
    • Recruiting
    • Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
    • Contact: Gennaro Scutiero, MD; Phone Number: +390532236576; Email: gennaro.scutiero@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Clinical data of patients undergoing total laparoscopic hysterectomies for larger uteri with uterus size of 12 gestational weeks (g.w.) or greater between. Inclusion criteria were as follows: (1) patients with uterine myomas or endometrioma; (2) patients who have good physical conditions and have no reproduction requirement; (3) patients with uterine size ≥ 12 weeks of gestation; and (4) patients who receive no hormone therapy in the recent 3 months. Exclusion criteria were as follows: (1) patients who are contraindicated to laparoscopic surgery; (2) patients with uterus size >16 g.w.; (3) patients with cervical myoma; (4) patients with uterine myoma associated with ovarian lesions; (5) patients with suspicious malignant gynecological disease diagnosed by ultrasound or MRI; and (6) patients with cervical cancer diagnosed by Thinprip cytologic test (TCT) and malignant endometrial lesions diagnosed by diagnostic curettage

Description

Inclusion Criteria:

• patients undergoing total laparoscopic hysterectomies for larger uteri

Exclusion Criteria:

• oncology

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 879/2022/Oss/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No