Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

NCT ID: NCT04904822

Last Updated: 2024-03-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hysterectomy Laparoscopy Uterine Bisection Large Uteri

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups parallel allocation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Closed envelopes containing allocations

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Vaginal bisection of uterus

Group Type EXPERIMENTAL

Vaginal bisection

Intervention Type PROCEDURE

Uterine bisection vaginally by scalpel 24

Control group

Abdominal bisection

Group Type EXPERIMENTAL

Abdominal bisection

Intervention Type PROCEDURE

Uterine bisection by endokinfe

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaginal bisection

Uterine bisection vaginally by scalpel 24

Intervention Type PROCEDURE

Abdominal bisection

Uterine bisection by endokinfe

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* large uterus ≥ 12weeks,
* benign pathology,
* mobile uterus
* BMI less than 30kg/m2

Exclusion Criteria

* unfit for laparoscopy,
* Extensive pelvic adhesions,
* Extensive endometriosis
* malignancy
* virgin cases
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayman S Dawood, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

uterine bisection

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.