A Modified Approach for Morbid Obese With Gynecologic Cancer

Not Applicable

• Conditions: Malignant Neoplasm of Cervix, Endometrium and Ovary
• Interventions: Procedure: Approach for cancer resection

• Registration Number: NCT03096652
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-24
• Last Update Submitted: 2017-03-24
• Study First Posted: 2017-03-30
• Last Update Posted: 2017-03-30
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oncologic outcome	2 weeks	measured by number of lymph nodes retrieved and rate of optimal debulking.

Secondary Outcome Measures

Name	Time	Method
Operative time	1 day
Blood loss	1 day	intraoperative
Hospital stay	1 month
Postoperative procedure related morbidity	1 month	Wound and chest complications

Trial Locations

Locations (1)

Oncology center Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt