Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

NCT ID: NCT03251677

Last Updated: 2019-09-30

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-03-01

Brief Summary

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The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

Detailed Description

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A prospective randomized open-label study was conducted. Women \>18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.

Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus \< 12 weeks, suspected malignancy and large adnexal masses (\>5cm). Peri-operative outcomes were compared.

Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.

Conditions

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Hysteromyoma

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 laparo hysterectomy

Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)

Group Type ACTIVE_COMPARATOR

Surgical procedure, Hysterectomy

Intervention Type PROCEDURE

Surgical removal of the uterus

Mini-lap hysterectomy

Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)

Group Type ACTIVE_COMPARATOR

Surgical procedure, Hysterectomy

Intervention Type PROCEDURE

Surgical removal of the uterus

Interventions

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Surgical procedure, Hysterectomy

Surgical removal of the uterus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Mobile uterus.
* Uterine size up to 12 weeks gestation.
* Benign lesions.

Exclusion Criteria

* Enlarged uterus \> 12 weeks gestation.
* Suspected malignancy.
* Large adnexal masses.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Shokeir

Prof. Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Shokeir

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Tarek Shokeir

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD/16.12.51

Identifier Type: -

Identifier Source: org_study_id

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