A Modified Approach for Morbid Obese With Gynecologic Cancer

Malignant Neoplasm of Cervix, Endometrium and Ovary Clinical Trial

Official title:

Gynecologic Cancer: a Modified Approach for Morbid Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096652
• Other study ID #: R/16.06.54
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2017
• Last updated: March 24, 2017
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Mansoura University
• Contact: Islam H Metwally, MSc, MRCS
• Phone: 01002985865
• Email: drislamhany[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm of Cervix, Endometrium and Ovary
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Approach for cancer resection

Locations

Country	Name	City	State
Egypt	Oncology center Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncologic outcome	measured by number of lymph nodes retrieved and rate of optimal debulking.	2 weeks
Secondary	Operative time		1 day
Secondary	Postoperative procedure related morbidity	Wound and chest complications	1 month
Secondary	Blood loss	intraoperative	1 day
Secondary	Hospital stay		1 month