A Modified Approach for Morbid Obese With Gynecologic Cancer | NCT03096652

Studies
A Modified Approach for Morbid Obese With Gynecologic Cancer

NCT03096652

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Mar 30, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Malignant Neoplasm of Cervix, Endometrium and Ovary

Interventions

Approach for cancer resection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Mar 22, 2017

First Submission Date that Met QC Criteria

Mar 24, 2017

First Posted Date

Mar 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2017

Last Update Posted Date

Mar 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Islam Hany Metwally, Assistant lecturer of surgical oncology, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Approach for cancer resection	Procedure		Midline approach Modified approach

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Operative time		1 day
Postoperative procedure related morbidity	Wound and chest complications	1 month

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Islam H Metwally, MSc, MRCS	Contact	01002985865	020	drislamhany@mans.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology center Mansoura University	Recruiting	Al Mansurah	Dakahlia Governorate	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided