A Modified Approach for Morbid Obese With Gynecologic Cancer

March 24, 2017 updated by: Islam Hany Metwally, Mansoura University

Gynecologic Cancer: a Modified Approach for Morbid Obese Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Oncology center Mansoura University
        • Contact:
        • Sub-Investigator:
          • Ahmed AbdAllah, MD
        • Sub-Investigator:
          • Amr F Elalfy, MSc
        • Sub-Investigator:
          • Shadi Awny, MSc
        • Sub-Investigator:
          • Mohamed Zuhdy, MSc
        • Sub-Investigator:
          • Mahmoud Mostafa, MSc
        • Sub-Investigator:
          • Sameh Roshdy, MD
        • Principal Investigator:
          • Islam H Metwally, MSc, MRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Midline approach
Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Procedure: Approach for cancer resection
Active Comparator: Modified approach
Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Procedure: Approach for cancer resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic outcome
Time Frame: 2 weeks
measured by number of lymph nodes retrieved and rate of optimal debulking.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 1 month
1 month
Operative time
Time Frame: 1 day
1 day
Postoperative procedure related morbidity
Time Frame: 1 month
Wound and chest complications
1 month
Blood loss
Time Frame: 1 day
intraoperative
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/16.06.54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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