Back to resultsA Modified Approach for Morbid Obese With Gynecologic Cancer
Primary Purpose
Malignant Neoplasm of Cervix, Endometrium and Ovary
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Approach for cancer resection
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Neoplasm of Cervix, Endometrium and Ovary focused on measuring gynecologic cancer - panniculectomy
Eligibility Criteria
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.
Sites / Locations
- Oncology center Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Midline approach
Modified approach
Arm Description
Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Outcomes
Primary Outcome Measures
Oncologic outcome
measured by number of lymph nodes retrieved and rate of optimal debulking.
Secondary Outcome Measures
Operative time
Postoperative procedure related morbidity
Wound and chest complications
Blood loss
intraoperative
Hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03096652
Brief Title
A Modified Approach for Morbid Obese With Gynecologic Cancer
Official Title
Gynecologic Cancer: a Modified Approach for Morbid Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Cervix, Endometrium and Ovary
Keywords
gynecologic cancer - panniculectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midline approach
Arm Type
Active Comparator
Arm Description
Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Arm Title
Modified approach
Arm Type
Active Comparator
Arm Description
Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).
Intervention Type
Procedure
Intervention Name(s)
Approach for cancer resection
Primary Outcome Measure Information:
Title
Oncologic outcome
Description
measured by number of lymph nodes retrieved and rate of optimal debulking.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
1 day
Title
Postoperative procedure related morbidity
Description
Wound and chest complications
Time Frame
1 month
Title
Blood loss
Description
intraoperative
Time Frame
1 day
Title
Hospital stay
Time Frame
1 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam H Metwally, MSc, MRCS
Phone
01002985865
Ext
020
Email
drislamhany@mans.edu.eg
Facility Information:
Facility Name
Oncology center Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam H Metwally, MSc, MRCS
Phone
01002985865
Ext
020
Email
drislamhany@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed AbdAllah, MD
First Name & Middle Initial & Last Name & Degree
Amr F Elalfy, MSc
First Name & Middle Initial & Last Name & Degree
Shadi Awny, MSc
First Name & Middle Initial & Last Name & Degree
Mohamed Zuhdy, MSc
First Name & Middle Initial & Last Name & Degree
Mahmoud Mostafa, MSc
First Name & Middle Initial & Last Name & Degree
Sameh Roshdy, MD
First Name & Middle Initial & Last Name & Degree
Islam H Metwally, MSc, MRCS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Modified Approach for Morbid Obese With Gynecologic Cancer
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