Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia

NCT ID: NCT03698604

Last Updated: 2018-10-09

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-08-01

Brief Summary

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The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

Detailed Description

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Research Questions:

Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?

Research Hypothesis:

In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.

Conditions

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Hysterectomy Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total Laparoscopic Hysterectomy

The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.

Group Type ACTIVE_COMPARATOR

Hysterectomy

Intervention Type PROCEDURE

Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Total Abdominal hysterectomy

The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.

Group Type ACTIVE_COMPARATOR

Hysterectomy

Intervention Type PROCEDURE

Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Interventions

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Hysterectomy

Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

The presence of perimenopausal bleeding

* Early stage endometrial carcinoma.
* Endometrial hyperplasia with/without atypia.

Exclusion Criteria

* Obese patients i.e., BMI\< 29 k.g/m2.
* Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
* Presence of adnexal mass.
* End stage endometrial carcinoma stage 3 \& 4.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rania Gamal Anwar Elskaan

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walid E Mohammed, MD

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Mortada E Ahmed, MD

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Locations

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Ain Shams Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TLH-TAH-EN

Identifier Type: -

Identifier Source: org_study_id

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