A Modified Approach for Morbid Obese With Gynecologic Cancer

NCT ID: NCT03096652

Last Updated: 2017-03-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.

Detailed Description

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Conditions

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Malignant Neoplasm of Cervix, Endometrium and Ovary

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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Midline approach

Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

Group Type ACTIVE_COMPARATOR

Approach for cancer resection

Intervention Type PROCEDURE

Modified approach

Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

Group Type ACTIVE_COMPARATOR

Approach for cancer resection

Intervention Type PROCEDURE

Interventions

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Approach for cancer resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Resectable (ovarian, endometrial, cervical) cancers.
2. Anaesthetically fit (ASA 1 and 2).
3. Abdominal pannus below symphysis pubis.

Exclusion Criteria

1. Non resectable gynecologic cancer.
2. Unfit patients.
3. Patients who refuse to share in the trial.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Islam Hany Metwally

Assistant lecturer of surgical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oncology center Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Islam H Metwally, MSc, MRCS

Role: CONTACT

01002985865 ext. 020

Facility Contacts

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Islam H Metwally, MSc, MRCS

Role: primary

01002985865 ext. 020

Other Identifiers

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R/16.06.54

Identifier Type: -

Identifier Source: org_study_id

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