A Modified Approach for Morbid Obese With Gynecologic Cancer

Mansoura University

Status: Unknown

Conditions: Malignant Neoplasm of Cervix, Endometrium and Ovary

Treatments: Procedure: Approach for cancer resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03096652

R/16.06.54

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Midline approach

Active Comparator group

Description:

Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

Treatment:

Procedure: Approach for cancer resection

Modified approach

Active Comparator group

Description:

Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

Treatment:

Procedure: Approach for cancer resection