Laparoscopic Assisted Doderlin Vaginal Hysterectomy

NCT ID: NCT03144414

Last Updated: 2020-01-28

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-20

Study Completion Date

2020-01-20

Brief Summary

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This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)

Detailed Description

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Conditions

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Laparoscopic Hysterectomy

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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LAVH

Laparoscopic Assisted Vaginal Hysterectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic hysterectomy

Intervention Type PROCEDURE

Laparoscopic hysterectomy

LADH

Laparoscopic Assisted Doderlin Vaginal Hysterectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic hysterectomy

Intervention Type PROCEDURE

Laparoscopic hysterectomy

Interventions

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Laparoscopic hysterectomy

Laparoscopic hysterectomy

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic Assisted Hysterectomy

Eligibility Criteria

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Inclusion Criteria

* Age \> 40 years.
* Uterine size ≤ 14weeks.
* Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
* No contraindication for laparoscopic surgery.

Exclusion Criteria

* Gynecologic malignancy.
* Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
* Large abdominal hernia
* Large ovarian mass
* History of previous laparotomy finding extensive adhesions
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1393

Identifier Type: -

Identifier Source: org_study_id

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