- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096652
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
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 Contact
- Name: Islam H Metwally, MSc, MRCS
- Phone Number: 020 01002985865
- Email: drislamhany@mans.edu.eg
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35516
- Recruiting
- Oncology center Mansoura University
-
Contact:
- Islam H Metwally, MSc, MRCS
- Phone Number: 020 01002985865
- Email: drislamhany@mans.edu.eg
-
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:
- Resectable (ovarian, endometrial, cervical) cancers.
- Anaesthetically fit (ASA 1 and 2).
- Abdominal pannus below symphysis pubis.
Exclusion Criteria:
- Non resectable gynecologic cancer.
- Unfit patients.
- 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).
|
|
Active Comparator: Modified approach
Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
|
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
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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